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

NCT07400965 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

DRUG

GLK-321 low dose BID

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

DRUG

GLK-321 mid dose BID

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

DRUG

GLK-321 high dose BID

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

DRUG

GLK-321 high dose QD

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

DRUG

Placebo BID

Twice daily administration of placebo to both eyes

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Study Director, MD · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-09-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400965 on ClinicalTrials.gov