Clinical trial NCT06329661: A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
Official title: A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change from baseline in corneal ECD
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: CYS-007 Investigational Site
state: California
city: Torrance
country: United States
facility: CYS-007 Investigational Site
state: California
city: Garner
country: United States
facility: CYS-007 Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: CYS-007 Investigational Site
state: North Carolina
city: Cranberry Township
country: United States
facility: CYS-007 Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: CYS-007 Investigational Site
state: Tennessee
Study officials:
affiliation: Novaliq GmbH
name: Sonja Krösser, PhD
role: STUDY_DIRECTOR
References: