Effect of Cequa™ in Subjects With Dry Eye Disease

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04357795
Study type	Interventional
Source	Sun Pharmaceutical Industries Limited
Contact
Status	Completed
Phase	Phase 4
Start date	June 29, 2020
Completion date	June 24, 2022

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