A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
Phase 4
Active, not recruiting
- Conditions
- Dry Eye Disease
- Interventions
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CYS-007 Investigational Site
🇺🇸Memphis, Tennessee, United States