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Clinical Trials in the USA / NCT07400965
Recruiting Phase 2

Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

NCT07400965 · tracked via the Priya Life Science USA tracker
Sponsor
Glaukos Corporation
Phase
Phase 2
Started
2025-12-05
Last updated
2026-02-27

Condition(s) studied

Demodex Blepharitis

Investigational drug(s) / intervention(s)

GLK-321 low dose BIDGLK-321 mid dose BIDGLK-321 high dose BIDGLK-321 high dose QDPlacebo BID

GLK-321 low dose BID: Twice daily administration of low dose GLK-321 to both eyes

GLK-321 mid dose BID: Twice daily administration of mid dose GLK-321 to both eyes

GLK-321 high dose BID: Twice daily administration of high dose GLK-321 to both eyes

GLK-321 high dose QD: Once daily administration of high dose GLK-321 to both eyes

Placebo BID: Twice daily administration of placebo to both eyes

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of study eyes with elimination of collarettes — 6 weeks
    Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment

Trial sites (1)

FacilityCityRegionStatus
Glaukos Clinical Study Site Newport Beach California Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400965 on ClinicalTrials.gov ↗ ← All trials in the USA