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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2025-07-30

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cyclosporine ophthalmic solution, 0.1% (VEVYE)

Cyclosporine ophthalmic solution, 0.1%; 12 months

Group Type ACTIVE_COMPARATOR

Cyclosporine ophthalmic solution, 0.1%

Intervention Type DRUG

Colorless and clear opthalmic solution containing 0.1% Cyclosporine

Saline solution, 0.6%

Saline solution, 0.6%; 12 months

Group Type PLACEBO_COMPARATOR

Saline solution, 0.6%

Intervention Type DRUG

Colorless and clear sodium chloride solution (0.6%)

Interventions

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Cyclosporine ophthalmic solution, 0.1%

Colorless and clear opthalmic solution containing 0.1% Cyclosporine

Intervention Type DRUG

Saline solution, 0.6%

Colorless and clear sodium chloride solution (0.6%)

Intervention Type DRUG

Other Intervention Names

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VEVYE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No