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A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study.
- Source :
-
Cornea [Cornea] 2021 Oct 01; Vol. 40 (10), pp. 1290-1297. - Publication Year :
- 2021
-
Abstract
- Purpose: To assess the efficacy, safety, and tolerability of a topical water-free cyclosporine A formulation (CyclASol 0.1% ophthalmic solution) in comparison with vehicle for the treatment of dry eye disease (DED).<br />Methods: Three hundred twenty-eight patients were enrolled in this prospective, 12-week, multicenter, randomized, double-masked, confirmatory, vehicle-controlled clinical study. After a 2-week run-in period, eligible DED patients were randomized 1:1 to either CyclASol 0.1% or vehicle twice daily. The primary efficacy endpoint was change from baseline in total corneal fluorescein staining (National Eye Institute scale), and the second hierarchical primary efficacy endpoint was change from baseline in the Ocular Surface Disease Index score, both at 4 weeks. Secondary efficacy and safety assessments included conjunctival lissamine green staining (Oxford scale), visual analog scales for dry eye symptoms, and adverse event.<br />Results: Treatment with CyclASol 0.1% was superior to vehicle in the primary endpoint: total corneal fluorescein staining at week 4 (Δ -0.8; 95% confidence interval, -1.3 to -0.4; P = 0.0002, analysis of covariance). This difference had already reached statistical significance after 2 weeks and was maintained throughout the study. The study did not statistically meet its second hierarchically tested primary endpoint: Ocular Surface Disease Index score (P = 0.2634). However, CyclASol 0.1% treatment showed statistically significant improvement compared with that of vehicle in the eye dryness score at week 4 (Δ -4.783; 95% confidence interval, -9.129 to -0.438; P = 0.0311).<br />Conclusions: CyclASol 0.1% was effective in treating signs and symptoms of DED. It significantly reduced corneal and conjunctival staining and improved ocular dryness compared with vehicle. CyclASol 0.1% was safe and showed excellent tolerability.<br /> (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Subjects :
- Administration, Ophthalmic
Adolescent
Adult
Aged
Aged, 80 and over
Conjunctiva metabolism
Cornea metabolism
Cyclosporine adverse effects
Double-Blind Method
Dry Eye Syndromes metabolism
Dry Eye Syndromes physiopathology
Female
Fluorescein metabolism
Fluorescent Dyes metabolism
Humans
Immunosuppressive Agents adverse effects
Male
Middle Aged
Ophthalmic Solutions
Prospective Studies
Staining and Labeling methods
Treatment Outcome
Water
Cyclosporine administration & dosage
Dry Eye Syndromes drug therapy
Immunosuppressive Agents administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1536-4798
- Volume :
- 40
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Cornea
- Publication Type :
- Academic Journal
- Accession number :
- 34481407
- Full Text :
- https://doi.org/10.1097/ICO.0000000000002633