Phase 3
Completed N=718
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
Source: ClinicalTrials.gov NCT01743729 ↗Enrolled (actual)
718
Serious AEs
1.0%
Results posted
Feb 2017
Primary outcomePrimary: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84 — 2.39; 2.40; -0.73; -0.71 units on a scale — p=0.6186
◆ Published Evidence
Highly cited
193citations · ~18 / year
Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study.
Summary
The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.
Linked Publications
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Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84 |
2.39; 2.40; -0.73; -0.71 | 0.6186 |
| PRIMARY Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84 |
69.68; 69.22; -35.30; -22.75 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Willing and able to read, sign and date the informed consent and HIPAA documents
- Willing and able to comply with all study procedures
- Be at least 18 years of age
- Patient-reported history of dry eye in both eyes
- A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
- Artificial tear use within the past 30 days
Exclusion Criteria
- Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
- Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study
- Any blood donation or significant loss of blood within 56 days of Visit 1
- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- Use of any prohibited medications at any time during the study unless otherwise specified
- Any significant illness that could interfere with study parameters
- History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period.
- Known history of alcohol and/or drug abuse
- Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Data sourced from ClinicalTrials.gov (NCT01743729) 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.