Jacksonville, Florida 32256

  • Dry Eye Disease

Purpose:

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.


Study summary:

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 enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.


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.


NCT ID:

NCT04357795


Primary Contact:

Head Clinical Development
Phone: +912266455645
Email: Clinical.Trials@sparcmail.com


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32256
United States

Frank Bowden, MD
Phone: 904-861-3858
Email: fbowden3@hotmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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