NCT06329661

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

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%

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Novaliq GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
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%)

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2024-03-26
• Last updated: 2025-08-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study