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NCT Number: NCT07400965

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

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.

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Key information

Conditions

Demodex Blepharitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glaukos Clinical Study Site

Newport Beach, California, 92663, United States

Location status: Recruiting

Location contact

Study Manager

CONTACT

[email protected]

949-739-8749

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLK-321 low dose BID

Drug

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

GLK-321 mid dose BID

Drug

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

GLK-321 high dose BID

Drug

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

GLK-321 high dose QD

Drug

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

placebo bid

Drug

Twice daily administration of placebo to both eyes

Primary outcomes

  1. Percentage of study eyes with elimination of collarettes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Manager

CONTACT

[email protected]

949-739-8749

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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