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

NCT06329661 | Completed Phase 4 FDA Drug

• 1 other identifier: CYS-007
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 6

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)

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in corneal ECD

  ECD measured as count/mm2 using specular microscopy

  12 months

Study Arms (2)

Cyclosporine ophthalmic solution, 0.1% (VEVYE)

ACTIVE COMPARATOR

Cyclosporine ophthalmic solution, 0.1%; 12 months

Drug: Cyclosporine ophthalmic solution, 0.1%

Saline solution, 0.6%

PLACEBO COMPARATOR

Saline solution, 0.6%; 12 months

Drug: Saline solution, 0.6%

Interventions

Cyclosporine ophthalmic solution, 0.1% DRUG

Colorless and clear opthalmic solution containing 0.1% Cyclosporine

Also known as: VEVYE

Cyclosporine ophthalmic solution, 0.1% (VEVYE)

Saline solution, 0.6% DRUG

Colorless and clear sodium chloride solution (0.6%)

Saline solution, 0.6%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novaliq GmbH: lead

Study Sites (6)

CYS-007 Investigational Site

Newport Beach, California, 92663, United States

Location

CYS-007 Investigational Site

Torrance, California, 90505, United States

Location

CYS-007 Investigational Site

Garner, North Carolina, 27529, United States

Location

CYS-007 Investigational Site

Shelby, North Carolina, 28150, United States

Location

CYS-007 Investigational Site

Cranberry Township, Pennsylvania, 16066, United States

Location

CYS-007 Investigational Site

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sonja Krösser, PhD

  Novaliq GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: April 22, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)