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

Completed · Phase 4

Conditions studied: Dry Eye Disease

In brief

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)

Key facts

Study ID

NCT06329661

Run by

Novaliq GmbH

People needed

204

Starts

2024-04-22

Expected to finish

2025-07-30

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• CYS-007 Investigational Site — Newport Beach, California, United States
• CYS-007 Investigational Site — Torrance, California, United States
• CYS-007 Investigational Site — Garner, North Carolina, United States
• CYS-007 Investigational Site — Shelby, North Carolina, United States
• CYS-007 Investigational Site — Cranberry Township, Pennsylvania, United States
• CYS-007 Investigational Site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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