# Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

> **NCT01421498** · PHASE3 · COMPLETED · sponsor: **Shire** · enrollment: 588 (actual)

## Conditions studied

- Keratoconjunctivitis Sicca
- Dry Eye Disease

## Interventions

- **DRUG:** Lifitegrast
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01421498
- **Lead sponsor:** Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-08-29
- **Primary completion:** 2012-04-28
- **Final completion:** 2012-04-28
- **Target enrollment:** 588 (ACTUAL)
- **Last updated:** 2021-06-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01421498

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01421498, "Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT01421498. Licensed CC0.

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