NCT07400965

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Demodex Blepharitis

Interventions

Type	Name	Description
DRUG	GLK-321 low dose BID	Twice daily administration of low dose GLK-321 to both eyes
DRUG	GLK-321 mid dose BID	Twice daily administration of mid dose GLK-321 to both eyes
DRUG	GLK-321 high dose BID	Twice daily administration of high dose GLK-321 to both eyes
DRUG	GLK-321 high dose QD	Once daily administration of high dose GLK-321 to both eyes
DRUG	Placebo BID	Twice daily administration of placebo to both eyes

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2026-02-10
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study