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

Phase 4

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Cyclosporine ophthalmic solution, 0.1%; Drug: Saline solution, 0.6%

• Registration Number: NCT06329661
• Lead Sponsor: Novaliq GmbH

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.

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Study Start: 2024-04-22
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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;
• Have a known allergy or sensitivity to the IMP or its components
• Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
• Randomized in a previous CyclASol trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine ophthalmic solution, 0.1% (VEVYE)	Cyclosporine ophthalmic solution, 0.1%	Cyclosporine ophthalmic solution, 0.1%; 12 months
Saline solution, 0.6%	Saline solution, 0.6%	Saline solution, 0.6%; 12 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in corneal ECD	12 months	ECD measured as count/mm2 using specular microscopy

Trial Locations

Locations (1)

CYS-007 Investigational Site; 🇺🇸 Memphis, Tennessee, United States