Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
Public ClinicalTrials.gov record NCT01421498. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)
Study identification
- NCT ID
- NCT01421498
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Shire
- Industry
- Enrollment
- 588 participants
Conditions and interventions
Conditions
Interventions
- Lifitegrast Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2011
- Primary completion
- Apr 27, 2012
- Completion
- Apr 27, 2012
- Last update posted
- Jun 10, 2021
2011 – 2012
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OPUS-1 Investigational Site | Waterbury | Connecticut | 06708 | — |
| OPUS-1 Investigational Site | Louisville | Kentucky | 40405 | — |
| OPUS-1 Investigational Site | Augusta | Maine | 04330 | — |
| OPUS-1 Investigational Site | Lewiston | Maine | 04243 | — |
| OPUS-1 Investigational Site | Andover | Massachusetts | 01840 | — |
| OPUS-1 Investigational Site | Lancaster | Massachusetts | 01523 | — |
| OPUS-1 Investigational Site | Quincy | Massachusetts | 02169 | — |
| OPUS-1 Investigational Site | Wakefield | Massachusetts | 01880 | — |
| OPUS-1 Investigational Site | Winchester | Massachusetts | 01890 | — |
| OPUS-1 Investigational Site | Derry | New Hampshire | 03038 | — |
| OPUS-1 Investigational Site | Manchester | New Hampshire | 03101 | — |
| OPUS-1 Investigational Site | Memphis | Tennessee | 38119 | — |
| OPUS-1 Investigational Site | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01421498, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2021 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01421498 live on ClinicalTrials.gov.