GLK-321 eye drops for Demodex blepharitis.
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Run by Glaukos Corporation · NCT07400965 · Data updated 2026-11-12
This trial will test whether different doses of GLK-321 eye drops can reduce the signs of Demodex blepharitis in adults with the condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Newport Beach, California) |
| Status | Recruiting |
| Started | December 5, 2025 |
| Main results expected | September 2026 |
| Study ends | November 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07400965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who have signs of Demodex blepharitis in at least one eye with best-corrected visual acuity of 20/80 or better and who are not pregnant or nursing would be ideal candidates.
✕Probably not a fit
Patients with ocular eczema or dermatitis, active non-blepharitis eye infection or inflammation, recent use of lid hygiene products, pregnancy or nursing, or recent enrollment in another investigational trial may not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, randomized, double-masked, placebo-controlled, dose-ranging parallel-group study compares multiple dosing regimens of GLK-321 (low, mid, high BID and high QD) against placebo. Participants must have signs of Demodex blepharitis in at least one eye and visual acuity of 20/80 Snellen or better in each eye. Key exclusions include ocular eczema/dermatitis, active non-blepharitis ocular infection or inflammation, recent use of lid hygiene products, pregnancy or nursing, and recent participation in other investigational trials. The trial is conducted at clinical sites sponsored by Glaukos with scheduled in-person visits for treatment and safety assessments.
Why it matters
Potential benefit: If successful, GLK-321 could lower Demodex mite burden and eyelid inflammation, improving symptoms and comfort for people with Demodex blepharitis.
How similar studies have gone: Similar topical antiparasitic approaches for Demodex blepharitis have shown promising results in other recent trials, so this program builds on prior positive findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Glaukos Clinical Study Site
Newport Beach, California, United States Recruiting
Study contacts
- Study coordinator: Study Manager
- Email: ClinicalResearch@Glaukos.com
- Phone: 949-739-8749
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.