Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Glaukos Corporation
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Percentage of study eyes with elimination of collarettes
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo BID
Placebo administered twice daily (BID) to both eyes
Intervention: Placebo BID (Drug)
GLK-321 low dose BID
Low dose of GLK-321 administered twice daily (BID) to both eyes
Intervention: GLK-321 low dose BID (Drug)
GLK-321 mid dose BID
Mid dose of GLK-321 administered twice daily (BID) to both eyes
Intervention: GLK-321 mid dose BID (Drug)
GLK-321 high dose BID
High dose of GLK-321 administered twice daily (BID) to both eyes
Intervention: GLK-321 high dose BID (Drug)
GLK-321 high dose QD
High dose of GLK-321 administered once daily (QD) to both eyes
Intervention: GLK-321 high dose QD (Drug)
Outcomes
Primary Outcomes
Percentage of study eyes with elimination of collarettes
Time Frame: 6 weeks
Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment
Secondary Outcomes
No secondary outcomes reported