Status:
COMPLETED
Effect of Cequa™ in Subjects With Dry Eye Disease
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollme...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04357795
Start Date
June 29 2020
End Date
June 24 2022
Last Update
February 6 2024
Active Locations (5)
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1
Eye Associates of Fort Myers, 4225 Evans Ave.
Fort Myers, Florida, United States, 33901
2
Bowden Eye and Associates, 7205 Bonneval Road
Jacksonville, Florida, United States, 32256
3
Eye Center of N Florida, 2500 Martin Luther King Jr Blvd
Panama City, Florida, United States, 32405
4
Kannarr Eye Care, 2521 N Broadway
Pittsburg, Kansas, United States, 66762