Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signs of Demodex blepharitis in at least one eye
• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye
Locations
United States
California
Glaukos Clinical Study Site
RECRUITING
Newport Beach
Contact Information
Primary
Study Manager
ClinicalResearch@Glaukos.com
949-739-8749
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2026-11
Participants
Target number of participants: 250
Treatments
Experimental: GLK-321 low dose BID
Low dose of GLK-321 administered twice daily (BID) to both eyes
Experimental: GLK-321 mid dose BID
Mid dose of GLK-321 administered twice daily (BID) to both eyes
Experimental: GLK-321 high dose BID
High dose of GLK-321 administered twice daily (BID) to both eyes
Experimental: GLK-321 high dose QD
High dose of GLK-321 administered once daily (QD) to both eyes
Placebo_comparator: Placebo BID
Placebo administered twice daily (BID) to both eyes
Related Therapeutic Areas
Sponsors
Leads: Glaukos Corporation