Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Glaukos Corporation
250 participants
Dec 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria5
- 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
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Interventions
Twice daily administration of low dose GLK-321 to both eyes
Twice daily administration of mid dose GLK-321 to both eyes
Twice daily administration of high dose GLK-321 to both eyes
Once daily administration of high dose GLK-321 to both eyes
Twice daily administration of placebo to both eyes
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07400965