NCT07400965PHASE2Recruiting
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Glaukos Corporation
Start Date
12/5/2025
Completion Date
11/1/2026
Summary
This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Signs of Demodex blepharitis in at least one eye
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye
Exclusion Criteria:
* Presence of eczema or dermatitis in the ocular region of either eye
* Use of lid hygiene products within 14 days of Screening
* Active ocular infection or inflammation, other than blepharitis, in either eye at Screening
* Women who are pregnant, planning a pregnancy, or nursing
* Have used an investigational drug or device within 30 days prior to Screening or concurrently enrolled in another investigational drug or device trial
Interventions
DRUG
GLK-321 low dose BID
DRUG
GLK-321 mid dose BID
DRUG
GLK-321 high dose BID
DRUG
GLK-321 high dose QD
DRUG
Placebo BID
Conditions
Demodex Blepharitis
Locations
Glaukos Clinical Study Site
Newport Beach, California 92663
United States