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

Novaliq

Status and phase: Active, not recruiting; Phase 4

Conditions: Dry Eye Disease

Treatments: Drug: Cyclosporine ophthalmic solution, 0.1%; Drug: Saline solution, 0.6%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06329661

CYS-007

Details and patient eligibility

About

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)

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups, including a placebo group

Cyclosporine ophthalmic solution, 0.1% (VEVYE)

Active Comparator group

Description:

Cyclosporine ophthalmic solution, 0.1%; 12 months

Treatment:

Drug: Cyclosporine ophthalmic solution, 0.1%

Saline solution, 0.6%

Placebo Comparator group

Description:

Saline solution, 0.6%; 12 months

Treatment:

Drug: Saline solution, 0.6%