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NCT01421498 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 588
- Enrollment target
NCT01421498: Completed Phase 3 study, sponsored by Shire.
NCT01421498 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 588 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421498, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 588 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.
Primary Outcome
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 poi
Interventions
- DRUG Placebo
- DRUG Lifitegrast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 588 participants |
| Start Date | 2011-08-29 |
| Est. Completion | 2012-04-28 |
| Phase | Phase 3 |
What the finished NCT01421498 record still lists
NCT01421498 is an interventional study that assigns participants to a tested intervention. The registered 588 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01421498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421498 about?
NCT01421498 is a clinical study titled "Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)". The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be...
What is the current status of trial NCT01421498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 588 participants. The study started on 2011-08-29. Estimated completion is 2012-04-28.
What interventions are being tested in trial NCT01421498?
The interventions under investigation include: Placebo (DRUG), Lifitegrast (DRUG).
Who is sponsoring clinical trial NCT01421498?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421498's enrollment target sits among peer trials
588 645th of 2000 higher than 1,356 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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