Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

Glaukos Corporation

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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…

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

Location

Glaukos Clinical Study Site
Newport Beach, California
ClinicalResearch@Glaukos.com 949-739-8749

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

Summary

Eligibility

Interventions

Location

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Details

Conditions