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

NCT07400965 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GLK-321-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Demodex Blepharitis

Keywords

demodex blepharitis

Outcome Measures

Primary Outcomes (1)

• Percentage of study eyes with elimination of collarettes

  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

Study Arms (5)

GLK-321 low dose BID

EXPERIMENTAL

Low dose of GLK-321 administered twice daily (BID) to both eyes

Drug: GLK-321 low dose BID

GLK-321 mid dose BID

EXPERIMENTAL

Mid dose of GLK-321 administered twice daily (BID) to both eyes

Drug: GLK-321 mid dose BID

GLK-321 high dose BID

EXPERIMENTAL

High dose of GLK-321 administered twice daily (BID) to both eyes

Drug: GLK-321 high dose BID

GLK-321 high dose QD

EXPERIMENTAL

High dose of GLK-321 administered once daily (QD) to both eyes

Drug: GLK-321 high dose QD

Placebo BID

PLACEBO COMPARATOR

Placebo administered twice daily (BID) to both eyes

Drug: Placebo BID

Interventions

GLK-321 low dose BID DRUG

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

GLK-321 low dose BID

GLK-321 mid dose BID DRUG

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

GLK-321 mid dose BID

GLK-321 high dose BID DRUG

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

GLK-321 high dose BID

GLK-321 high dose QD DRUG

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

GLK-321 high dose QD

Placebo BID DRUG

Twice daily administration of placebo to both eyes

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signs of Demodex blepharitis in at least one eye
• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaukos Clinical Study Site

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Interventions

BID protein, human

Study Officials

• Study Director, MD

  Glaukos Corporation

  STUDY DIRECTOR

Central Study Contacts

Study Manager

CONTACT

949-739-8749; ClinicalResearch@Glaukos.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)