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

CompletedPhase 4

Sponsor: Novaliq GmbH

Conditions: Dry Eye Disease, Endothelial Cell

Interventions: Cyclosporine ophthalmic solution, 0.1%, Saline solution, 0.6%

Countries: United States

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* 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 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

Locations (6)

Newport Beach, California, United States
Torrance, California, United States
Garner, North Carolina, United States
Shelby, North Carolina, United States
Cranberry Township, Pennsylvania, United States
Memphis, Tennessee, United States