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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07400965

Enrollment

250

Registered

2026-02-10

Start date

2025-12-05

Completion date

2026-11-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Demodex Blepharitis

Keywords

demodex blepharitis

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

CONTACTStudy Manager

ClinicalResearch@Glaukos.com949-739-8749

STUDY_DIRECTORStudy Director, MD

Glaukos Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026