Phase 3
Completed N=711
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Source: ClinicalTrials.gov NCT02284516 ↗Enrolled (actual)
711
Serious AEs
1.1%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 — 69.0; 68.3; -30.7; -37.9 units on a scale — p==0.0007
◆ Published Evidence
Highly cited
210citations · ~23 / year
Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3).
Summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
Linked Publications (2)
-
Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3).
-
Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 |
69.0; 68.3; -30.7; -37.9 | =0.0007 sig |
| SECONDARY Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 |
69.0; 68.3; -15.0; -22.9; -23.9; -33.2 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient-reported history of Dry Eye Disease in both eyes.
- Use of over the counter artificial tears within the past 30 days.
- A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
- Able and willing to comply with all study procedures.
Exclusion Criteria
- Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
- Unwilling to stop wearing contact lenses during the study.
- LASIK or other ocular surgical procedures within 12 months prior to or during the study.
- Use of prohibited medications
- Significant medical conditions that could affect the study parameters.
Data sourced from ClinicalTrials.gov (NCT02284516) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.