Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion

OTX101-2019-001

This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

2020-06-29

2022-06-24

2022-06-24

Completed

Early phase I

135

Inclusion Criteria: 1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months. 2. Aged of at least 18 years. 3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale. 4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale. 5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit Exclusion Criteria: 1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit. 2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion. 3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye. 4. Subjects who had already Use initiated any systemic or topical ocular medication.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}

2024-02-06