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

Dry Eye Disease Clinical Trial

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329661
• Other study ID #: CYS-007
• Status: Recruiting
• Phase: Phase 4
• Start date: April 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Novaliq GmbH
• Contact: Alice Meides, PhD
• Phone: 0622150259
• Email: ameides[@]novaliq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine ophthalmic solution, 0.1%
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
• Saline solution, 0.6%
Colorless and clear sodium chloride solution (0.6%)

Locations

Country	Name	City	State
United States	CYS-007 Investigational Site	Cranberry Township	Pennsylvania
United States	CYS-007 Investigational Site	Garner	North Carolina
United States	CYS-007 Investigational Site	Memphis	Tennessee
United States	CYS-007 Investigational Site	Newport Beach	California
United States	CYS-007 Investigational Site	Shelby	North Carolina
United States	CYS-007 Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in corneal ECD	ECD measured as count/mm2 using specular microscopy	12 months