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%

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)

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Saline solution, 0.6%; Drug: Cyclosporine ophthalmic solution, 0.1%

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 Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • CYS-007 Investigational Site
    • Torrance, California, United States, 90505
      • CYS-007 Investigational Site
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • CYS-007 Investigational Site
    • Shelby, North Carolina, United States, 28150
      • CYS-007 Investigational Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • CYS-007 Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • CYS-007 Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyclosporine ophthalmic solution, 0.1% (VEVYE); Cyclosporine ophthalmic solution, 0.1%; 12 months	Drug: Cyclosporine ophthalmic solution, 0.1%; Colorless and clear opthalmic solution containing 0.1% Cyclosporine; Other Names: VEVYE
Placebo Comparator: Saline solution, 0.6%; Saline solution, 0.6%; 12 months	Drug: Saline solution, 0.6%; Colorless and clear sodium chloride solution (0.6%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal ECD	ECD measured as count/mm2 using specular microscopy	12 months

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Sonja Krösser, PhD, Novaliq GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: CYS-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No