RecruitingPhase 2NCT07400965

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


Sponsor

Glaukos Corporation

Enrollment

250 participants

Start Date

Dec 5, 2025

Study Type

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

Min Age: 18 Years

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

DRUGGLK-321 low dose BID

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

DRUGGLK-321 mid dose BID

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

DRUGGLK-321 high dose BID

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

DRUGGLK-321 high dose QD

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

DRUGPlacebo BID

Twice daily administration of placebo to both eyes


Locations(1)

Glaukos Clinical Study Site

Newport Beach, California, United States

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NCT07400965