Clinical Trial Results:
Therapeutic Equivalence (non-inferiority), Randomized, Observer-blind, two Parallel Group, Clinical Trial for Comparing the Efficacy and Tolerability of a new Generic Preservative-Free Formulation of Latanoprost 50μg/ml/Timolol 5mg/ml Eye Drops vs Xalacom® Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension.
Summary
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EudraCT number |
2017-004524-29 |
Trial protocol |
GR |
Global end of trial date |
17 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Mar 2019
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First version publication date |
31 Mar 2019
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Other versions |
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 |
BECRO/PHN/LATIM
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pharmathen S.A.
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Sponsor organisation address |
6 Dervenakion Str, Pallini Attica, Greece, 15351
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Public contact |
Lida Kalantzi, PhD
Head of Scientific Affairs, Pharmathen S.A. , +30 2106604300, lkalantzi@pharmathen.com
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Scientific contact |
Lida Kalantzi, PhD
Head of Scientific Affairs, Pharmathen S.A. , +30 2106604300, lkalantzi@pharmathen.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 |
24 Jan 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Dec 2018
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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 |
To confirm the clinical non-inferiority of a generic ophthalmic product of Latanoprost 50μg/ml/Timolol 5mg/ml fixed combination which is preservative-free (test) compared with the marketed preservative-containing Xalacom® (reference) eye drops in patients with open angle glaucoma or ocular hypertension by examining the change of IOP at 8:00am from end of study to baseline.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in
compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jun 2018
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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 |
Greece: 210
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Worldwide total number of subjects |
210
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EEA total number of subjects |
210
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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) |
53
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From 65 to 84 years |
145
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85 years and over |
12
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Recruitment
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Recruitment details |
Study sites: Ophthalmiatreio Athens, General Hospital of Larissa, General University Hospital of Athens Attikon, General University Hospital of Thessaloniki AXEPA, IASO Thessalias, General University Hospital of Patra, General Hospital of Thessaloniki Ippokrateio, NIMITS 417 | |||||||||||||||||||||
Pre-assignment
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Screening details |
This study was conducted in 8 clinical sites in Greece between June 29, 2018 and December 17,2018. | |||||||||||||||||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||||||||||||||
Roles blinded |
Investigator [1] | |||||||||||||||||||||
Blinding implementation details |
Observer-blind
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||||||||||||||
Arm description |
Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free | |||||||||||||||||||||
Arm type |
Test | |||||||||||||||||||||
Investigational medicinal product name |
Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
One drop of the Test product containing Latanoprost 50μg/ml and Timolol 5mg/ml fixed combination preservative-free in each eye once daily in the evening (approximately at 20:00 pm).
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Arm title
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Reference | |||||||||||||||||||||
Arm description |
XALACOM® | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Xalacom®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
One drop of XALACOM® containing Latanoprost 50μg/ml and Timolol 5mg/ml in each eye once daily in the evening (approximately at 20:00 pm).
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Due to differences in the packaging of the study medication, the investigator measuring IOP was masked to study medication. |
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Baseline characteristics reporting groups
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Reporting group title |
Test
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Reporting group description |
Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Reference
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Reporting group description |
XALACOM® | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
PP
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The per protocol (PP) population includes all those of the ITT population who had no major protocol deviations, who completed IOP measurements within the allowed time frames, who completed at least 12 weeks of treatment with the last dose administered before the 12-week visit, and who did not take prohibited concurrent medication.
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End points reporting groups
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Reporting group title |
Test
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Reporting group description |
Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free | ||
Reporting group title |
Reference
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Reporting group description |
XALACOM® | ||
Subject analysis set title |
PP
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per protocol (PP) population includes all those of the ITT population who had no major protocol deviations, who completed IOP measurements within the allowed time frames, who completed at least 12 weeks of treatment with the last dose administered before the 12-week visit, and who did not take prohibited concurrent medication.
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End point title |
Change in IOP at 8:00am in study eye from end of treatment (week 12) to baseline (week 0) | ||||||||||||
End point description |
The change in IOP at 8:00 am in study eye from end of treatment (week 12) to baseline (week 0)
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End point type |
Primary
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End point timeframe |
End of treatment (week 12) to baseline (week 0)
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Statistical analysis title |
IOP change | ||||||||||||
Statistical analysis description |
The analysis of covariance (ANCOVA) model was used to analyse the change in IOP with baseline IOP as the covariate, and treatment as a factor. The treatment difference and a two-sided 95% confidence interval (CI) for the difference were calculated. The preservative-free latanoprost/timolol eye drops (Test) was considered to be non-inferior to the marketed Xalacom® including preservative (Reference), if the upper limit of the 95% CI of the difference was < 1.5 mmHg
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.624
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.094 | ||||||||||||
upper limit |
1.341 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.364
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Notes [1] - Non-inferiority |
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End point title |
Change in IOP at 12:00 pm from 12 weeks to baseline | ||||||||||||
End point description |
The change in IOP at 12:00 am in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
End of treatment (week 12) to baseline (week 0)
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Statistical analysis title |
IOP change at 12:00 pm from 12 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 12:00 pm from weeks 12 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate, and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.569
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.086 | ||||||||||||
upper limit |
1.225 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.332
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End point title |
IOP change at 16:00 pm from 12 weeks to baseline | ||||||||||||
End point description |
The change in IOP at 16:00 pm in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
End of treatment (week 12) to baseline (week 0)
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Statistical analysis title |
IOP change at 16:00 pm from 12 weeks to baseline | ||||||||||||
Statistical analysis description |
The scondary endpoint "change in IOP at 16:00 pm from weeks 12 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.306
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.392 | ||||||||||||
upper limit |
1.003 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.354
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Notes [2] - Non-inferiority |
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End point title |
Change in IOP at 8:00 am in study eye from 6 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 8:00 am in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 6 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 8:00 am from 6 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 8:00 am from weeks 6 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.511
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.188 | ||||||||||||
upper limit |
1.21 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.355
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End point title |
Change in IOP at 12:00 pm in study eye from 6 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 12:00 pm in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 6 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 12:00 pm from 6 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 8:00 am from weeks 6 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.471
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.197 | ||||||||||||
upper limit |
1.139 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.339
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End point title |
Change in IOP at 16:00 pm in study eye from 6 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 16:00 pm in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 6 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 16:00 pm from 6 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 16:00 pm from 6 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.152
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.572 | ||||||||||||
upper limit |
0.875 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.367
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End point title |
Change in IOP at 8:00 am in study eye from 2 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 8:00 am in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 2 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 8:00 am from 2 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 8:00 am from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.121
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.617 | ||||||||||||
upper limit |
0.858 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.374
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End point title |
Change in IOP at 12:00 pm in study eye from 2 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 12:00 pm in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 2 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 12:00 pm from weeks 2 to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 12:00 pm from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.049
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.783 | ||||||||||||
upper limit |
0.684 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.372
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End point title |
Change in IOP at 16:00 pm in study eye from 2 weeks to baseline | ||||||||||||
End point description |
Change in IOP at 16:00 pm in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
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End point type |
Secondary
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End point timeframe |
From week 2 to baseline (week 0)
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Statistical analysis title |
Change in IOP at 16:00 pm from 2 weeks to baseline | ||||||||||||
Statistical analysis description |
The secondary endpoint "change in IOP at 16:00 pm from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
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Comparison groups |
Test v Reference
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.044
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.71 | ||||||||||||
upper limit |
0.798 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.382
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Adverse events information
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Timeframe for reporting adverse events |
From baseline to end of treatment (12 weeks)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Test
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Reference
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |