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

February 24, 2026 updated by: Glaukos Corporation

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLK-321 low dose BID
Low dose of GLK-321 administered twice daily (BID) to both eyes
Drug: GLK-321 low dose BID
Twice daily administration of low dose GLK-321 to both eyes
Experimental: GLK-321 mid dose BID
Mid dose of GLK-321 administered twice daily (BID) to both eyes
Drug: GLK-321 mid dose BID
Twice daily administration of mid dose GLK-321 to both eyes
Experimental: GLK-321 high dose BID
High dose of GLK-321 administered twice daily (BID) to both eyes
Drug: GLK-321 high dose BID
Twice daily administration of high dose GLK-321 to both eyes
Experimental: GLK-321 high dose QD
High dose of GLK-321 administered once daily (QD) to both eyes
Drug: GLK-321 high dose QD
Once daily administration of high dose GLK-321 to both eyes
Placebo Comparator: Placebo BID
Placebo administered twice daily (BID) to both eyes
Drug: Placebo BID
Twice daily administration of placebo to both eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Investigators

  • Study Director: Study Director, MD, Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLK-321-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Demodex Blepharitis

Clinical Trials on GLK-321 low dose BID

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe