| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02284516 | A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) | PHASE3 | COMPLETED | 711 | — | — | Nov 6, 2014 | Oct 5, 2015 | Jun 11, 2021 | 41 | United States |
| NCT01743729 | A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye | PHASE3 | COMPLETED | 720 | — | — | Dec 7, 2012 | Oct 1, 2013 | Jun 23, 2021 | 31 | United States |
| NCT01636206 | Safety Study of Lifitegrast to Treat Dry Eye | PHASE3 | COMPLETED | 332 | — | — | Oct 16, 2012 | Mar 3, 2014 | Jun 11, 2021 | 23 | United States |
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Eye dryness score was assessed on a visual analogue scale (a 7-item \[burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain\], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
| Arm | Type | Description |
|---|---|---|
| Lifitegrast | EXPERIMENTAL | Lifitegrast Ophthalmic Solution 5%, BID for 84 days |
| Placebo | PLACEBO_COMPARATOR | Placebo to match active treatment, BID for 84 days |
| Name | Type | Description |
|---|---|---|
| Lifitegrast | DRUG | Lifitegrast Ophthalmic Solution 5%, BID for 84 days |
| Placebo | DRUG | Placebo to match active treatment, BID for 84 days |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD, ABBV-319 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | GRF312 5% |
| Bausch + Lomb Corporation | BLCO | 1 | PHASE2 | Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Perfluorohexyloctane, Vehicle |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 2 | NA | Undisclosed |
| Harrow, Inc. | HROW | 1 | — | Undisclosed |