Clinical Trial Results:
A Phase 3 Randomised, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement with Phacoemulsification
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Summary
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EudraCT number |
2012-000867-25 |
Trial protocol |
NL AT |
Global end of trial date |
18 Mar 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jan 2019
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First version publication date |
26 Jan 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OMS302-ILR-004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01579565 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Omeros Corporation
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Sponsor organisation address |
201 Elliott Ave W, Seattle, United States, 98119
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Public contact |
Regulatory Affairs, Novella Clinical, +44 01438221122, vvanaaken@novellaclinical.com
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Scientific contact |
Regulatory Affairs, Novella Clinical, +44 01438221122, vvanaaken@novellaclinical.com
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Sponsor organisation name |
Omeros Corporation
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Sponsor organisation address |
201 Elliott Avenue West, Seattle, United States, 98119
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Public contact |
Soyoung Han, Omeros Corporation, 011 12066765000, shan@omeros.com
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Scientific contact |
Andrea Kessler, Omeros Corporation, 011 12066765000, akessler@omeros.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Apr 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Jan 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Mar 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The co-primary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: Intraoperative pupil diameter and Pain during the early postoperative period.
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Protection of trial subjects |
N/A
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Background therapy |
Preoperative mydriatics | ||
Evidence for comparator |
None | ||
Actual start date of recruitment |
28 Feb 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 12
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Country: Number of subjects enrolled |
United States: 404
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Worldwide total number of subjects |
416
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
107
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From 65 to 84 years |
295
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85 years and over |
14
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
N/A | |||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Randomized
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Assessor, Subject | |||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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OMS302 | |||||||||||||||||||||||||||
Arm description |
OMS302 diluted in irrigation solution | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
OMS302
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for intraocular irrigation
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Routes of administration |
Intraocular use
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Dosage and administration details |
For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle
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Arm title
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Placebo | |||||||||||||||||||||||||||
Arm description |
Placebo diluted in irrigation solution | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for intraocular irrigation
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Routes of administration |
Intraocular use
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Dosage and administration details |
For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.
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Period 2
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Period 2 title |
Treated
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Is this the baseline period? |
No | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||||||||
Blinding implementation details |
None
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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OMS302 | |||||||||||||||||||||||||||
Arm description |
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
OMS302
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for intraocular irrigation
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Routes of administration |
Intraocular use
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Dosage and administration details |
For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.
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Arm title
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Placebo | |||||||||||||||||||||||||||
Arm description |
Placebo diluted in Balance Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for intraocular irrigation
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Routes of administration |
Intraocular use
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Dosage and administration details |
For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.
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Baseline characteristics reporting groups
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Reporting group title |
OMS302
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Reporting group description |
OMS302 diluted in irrigation solution | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo diluted in irrigation solution | ||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Completed randomization
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects who completed randomization.
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End points reporting groups
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Reporting group title |
OMS302
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Reporting group description |
OMS302 diluted in irrigation solution | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo diluted in irrigation solution | ||
Reporting group title |
OMS302
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Reporting group description |
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo diluted in Balance Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. | ||
Subject analysis set title |
Completed randomization
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Subjects who completed randomization.
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End point title |
Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery | ||||||||||||
End point description |
The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
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End point type |
Primary
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End point timeframe |
From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
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Statistical analysis title |
1. Primary | ||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
395
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
< 0.0001 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.59
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.494 | ||||||||||||
upper limit |
0.686 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.049
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End point title |
Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoepratively | ||||||||||||
End point description |
The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.
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End point type |
Primary
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End point timeframe |
12 hours postoperatively
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Statistical analysis title |
2. Primary | ||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
404
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0002 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.917 | ||||||||||||
upper limit |
-2.244 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.192
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End point title |
Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up | |||||||||
End point description |
The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.
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End point type |
Secondary
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End point timeframe |
at time of cortical clean-up (i.e., end of surgical procedure)
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Statistical analysis title |
3. Secondary | |||||||||
Statistical analysis description |
Statistical Analysis 1 for Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
395
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.0001 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Pupil Diameter Less Than 6 mm Anytime During Surgery | |||||||||
End point description |
The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm
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End point type |
Secondary
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End point timeframe |
Intraoperative
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Statistical analysis title |
4. Secondary | |||||||||
Statistical analysis description |
Statistical Analysis 1 for Pupil Diameter Less Than 6 mm Anytime During Surgery
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
395
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.0001 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively | |||||||||
End point description |
Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively
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End point type |
Secondary
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End point timeframe |
12 hours postoperatively
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Statistical analysis title |
5. Secondary | |||||||||
Statistical analysis description |
Statistical Analysis 1 for Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
404
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.076 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively | |||||||||
End point description |
The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.
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End point type |
Secondary
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End point timeframe |
12 hours postoperatively
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Statistical analysis title |
6. Secondary | |||||||||
Statistical analysis description |
Statistical Analysis 1 for Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
404
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.0806 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Ocular Pain VAS Score on Day 1 | ||||||||||||
End point description |
VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.
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End point type |
Secondary
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End point timeframe |
One day postoperatively
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Statistical analysis title |
7. Secondary | ||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Ocular Pain VAS Score on Day 1
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
406
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0002 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Confidence interval |
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End point title |
Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery | |||||||||||||||||||||
End point description |
Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.
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End point type |
Secondary
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End point timeframe |
Six hours postoperatively
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Statistical analysis title |
8. Secondary | |||||||||||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
402
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
< 0.3923 | |||||||||||||||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||||||||||||||
Confidence interval |
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End point title |
Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery | |||||||||||||||||||||
End point description |
Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.
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End point type |
Secondary
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End point timeframe |
One day postoperatively
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Statistical analysis title |
9. Secondary | |||||||||||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery
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Comparison groups |
OMS302 v Placebo
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Number of subjects included in analysis |
406
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
< 0.006 | |||||||||||||||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
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End point title |
Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1 | ||||||||||||
End point description |
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
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End point type |
Secondary
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End point timeframe |
One day postoperatively
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|
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Statistical analysis title |
10. Secondary | ||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1
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Comparison groups |
OMS302 v Placebo
|
||||||||||||
Number of subjects included in analysis |
406
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.3286 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Confidence interval |
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|
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End point title |
Postoperative Best Corrected Visual Acuity (BVCA) on Day 1 | ||||||||||||
End point description |
Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.
|
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End point type |
Secondary
|
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End point timeframe |
One day postoperatively
|
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|
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Statistical analysis title |
11. Secondary | ||||||||||||
Statistical analysis description |
Statistical Analysis 1 for Postoperative Best Corrected Visual Acuity (BVCA) on Day 1
|
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Comparison groups |
OMS302 v Placebo
|
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Number of subjects included in analysis |
404
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.2361 | ||||||||||||
Method |
Wilcoxon rank-sum test | ||||||||||||
Confidence interval |
|||||||||||||
|
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End point title |
Systemic Pharmacokinetics (PK) of OMS302 | |||||||||||||||
End point description |
Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.
|
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End point type |
Secondary
|
|||||||||||||||
End point timeframe |
24 hours
|
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|
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| No statistical analyses for this end point | ||||||||||||||||
|
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Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
90 days
|
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
|
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Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
OMS302
|
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Reporting group description |
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
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Reporting group description |
Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Frequency threshold for reporting non-serious adverse events: 0.05% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
