NCT07400965 Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
| NCT ID | NCT07400965 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Glaukos Corporation |
| Condition | Demodex Blepharitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2025-12-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Study Director, MD
STUDY DIRECTOR
Glaukos Corporation
Frequently Asked Questions
Who can join the NCT07400965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Demodex Blepharitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07400965 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07400965 currently recruiting?
Yes, NCT07400965 is actively recruiting participants. Contact the research team at ClinicalResearch@Glaukos.com for enrollment information.
Where is the NCT07400965 trial being conducted?
This trial is being conducted at Newport Beach, United States.
Who is sponsoring the NCT07400965 clinical trial?
NCT07400965 is sponsored by Glaukos Corporation. The principal investigator is Study Director, MD at Glaukos Corporation. The trial plans to enroll 250 participants.