Effect of Cequa™ in Subjects With Dry Eye Disease

Completed · Phase 4

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT04357795

Run by

Sun Pharmaceutical Industries Limited

People needed

135

Starts

2020-06-29

Expected to finish

2022-06-24

Last updated by the study team

2024-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
• Aged of at least 18 years.
• Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
• Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
• Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit

You may not qualify if…

• Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
• Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
• Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
• Subjects who had already Use initiated any systemic or topical ocular medication.

Where it is running

• Eye Associates of Fort Myers, 4225 Evans Ave. — Fort Myers, Florida, United States
• Bowden Eye and Associates, 7205 Bonneval Road — Jacksonville, Florida, United States
• Eye Center of N Florida, 2500 Martin Luther King Jr Blvd — Panama City, Florida, United States
• Kannarr Eye Care, 2521 N Broadway — Pittsburg, Kansas, United States
• Texas Eye and Laser Center, 1872 Norwood Dr. #200 — Hurst, Texas, United States

Full record on ClinicalTrials.gov

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