Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GLK-321 low dose BID, GLK-321 mid dose BID, GLK-321 high dose BID, GLK-321 high dose QD.
- Who it may be relevant to
- Registry conditions: Demodex Blepharitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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
Primary outcome measures
- Percentage of study eyes with elimination of collarettes [Time frame: 6 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Glaukos Clinical Study Site — Newport Beach
Identifiers
NCT: NCT07400965 · GLK-321-01