Clinical Trial Results:
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily
Summary
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EudraCT number |
2017-002728-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Jan 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Dec 2017
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First version publication date |
21 Dec 2017
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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 |
C-12-028
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01698814 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Alcon Research
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Sponsor organisation address |
6201 S. Freeway, Fort Worth, United States, 76134
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Public contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, Dennis.wong@novartis.com
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Scientific contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, Dennis.wong@novartis.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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Jan 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jan 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jan 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 purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
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Protection of trial subjects |
Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical
Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Oct 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 |
United States: 499
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Worldwide total number of subjects |
499
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EEA total number of subjects |
0
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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) |
68
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Adolescents (12-17 years) |
7
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Adults (18-64 years) |
413
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 15 study centers located in the United States. | |||||||||||||||||||||
Pre-assignment
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Screening details |
This reporting group includes all randomized and treated subjects (499). | |||||||||||||||||||||
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 |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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AL-4943A | |||||||||||||||||||||
Arm description |
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
AL-4943A Ophthalmic Solution
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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 instilled in both eyes once daily for up to 6 weeks
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Arm title
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AL-4943A Vehicle | |||||||||||||||||||||
Arm description |
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks | |||||||||||||||||||||
Arm type |
Placebo Comparator | |||||||||||||||||||||
Investigational medicinal product name |
AL-4943A Ophthalmic Solution Vehicle
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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 instilled in both eyes once daily for up to 6 weeks
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Baseline characteristics reporting groups
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Reporting group title |
AL-4943A
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Reporting group description |
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
AL-4943A Vehicle
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Reporting group description |
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
AL-4943A
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Reporting group description |
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks | ||
Reporting group title |
AL-4943A Vehicle
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Reporting group description |
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
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End point title |
Adverse Events [1] | |||||||||||||||||||||
End point description |
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. This reporting group includes all randomized subjects who received study medication.
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End point type |
Primary
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End point timeframe |
An average of 6 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned or conducted. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse Events (AE) were collected for the duration of the study (3 months).
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Adverse event reporting additional description |
An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. This reporting group includes all randomized subjects who received study medication. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
AL-4943A
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Reporting group description |
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks | |||||||||||||||
Reporting group title |
AL-4943A Vehicle
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Reporting group description |
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events occurred above the 5% threshold. |
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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 |