GLK-321 eye drops for 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
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 |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Newport Beach, California) |
| Trial ID | NCT07400965 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Similar topical antiparasitic approaches for Demodex blepharitis have shown promising results in other recent trials, so this program builds on prior positive findings.
Eligibility criteria
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 this trial is running
Newport Beach, California
- Glaukos Clinical Study Site — Newport Beach, California, United States (Recruiting)
Study contacts
- Study coordinator: Study Manager
- Email: ClinicalResearch@Glaukos.com
- Phone: 949-739-8749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.