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COMPLETED
NCT06329661
PHASE4

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine

Sponsor: Novaliq GmbH

View on ClinicalTrials.gov

Summary

The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)

Official title: A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2024-04-22

Completion Date

2025-07-30

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DRUG

Cyclosporine ophthalmic solution, 0.1%

Colorless and clear opthalmic solution containing 0.1% Cyclosporine

DRUG

Saline solution, 0.6%

Colorless and clear sodium chloride solution (0.6%)

Locations (6)

CYS-007 Investigational Site

Newport Beach, California, United States

CYS-007 Investigational Site

Torrance, California, United States

CYS-007 Investigational Site

Garner, North Carolina, United States

CYS-007 Investigational Site

Shelby, North Carolina, United States

CYS-007 Investigational Site

Cranberry Township, Pennsylvania, United States

CYS-007 Investigational Site

Memphis, Tennessee, United States