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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 588 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421498
The ClinicalTrials.gov registry entry for NCT01421498 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 588 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01421498 reports 0 study locations.
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.
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