Effect of Cequa™ in Subjects With Dry Eye Disease

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Global FZE
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions

Criteria

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.