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%

Novaliq GmbH1 site in 1 country204 target enrollmentApril 22, 2024

ConditionsDry Eye Disease

InterventionsCyclosporine ophthalmic solution, 0.1%Saline solution, 0.6%

DrugsCyclosporine ophthalmic solution, 0.1%Saline solution, 0.6%

Overview

Phase: Phase 4
Intervention: Cyclosporine ophthalmic solution, 0.1%
Conditions: Dry Eye Disease
Sponsor: Novaliq GmbH
Enrollment: 204
Locations: 1
Primary Endpoint: Change from baseline in corneal ECD
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 22, 2024

End Date

July 30, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novaliq GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be at least 18 years of age;
•Provide written informed consent;
•Have a subject reported history of dry eye disease (DED) in both eyes
•Be able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria

•Be a woman who is pregnant, nursing, or planning a pregnancy;
•Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
•Clinically significant slit-lamp findings or abnormal lid anatomy at screening
•Ocular/periocular malignancy
•History of herpetic keratitis
•Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophy or other endothelial dystrophy, significant guttata
•Ongoing ocular or systemic infection at screening or baseline
•Presence of uncontrolled systemic diseases
•Presence of known allergy and/or sensitivity to the study drug or its components
•Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period;