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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

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Conditions

Demodex Blepharitis

Locations

Glaukos Clinical Study Site

Newport Beach, California 92663

United States