Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

Conditions

• Demodex Blepharitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GLK-321 low dose BID — DRUG
  Twice daily administration of low dose GLK-321 to both eyes
• GLK-321 mid dose BID — DRUG
  Twice daily administration of mid dose GLK-321 to both eyes
• GLK-321 high dose BID — DRUG
  Twice daily administration of high dose GLK-321 to both eyes
• GLK-321 high dose QD — DRUG
  Once daily administration of high dose GLK-321 to both eyes
• Placebo BID — DRUG
  Twice daily administration of placebo to both eyes

Study Details

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.

Key Dates

Start date

Dec 5, 2025

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GLK-321 low dose BID
  Low dose of GLK-321 administered twice daily (BID) to both eyes
• Experimental: GLK-321 mid dose BID
  Mid dose of GLK-321 administered twice daily (BID) to both eyes
• Experimental: GLK-321 high dose BID
  High dose of GLK-321 administered twice daily (BID) to both eyes
• Experimental: GLK-321 high dose QD
  High dose of GLK-321 administered once daily (QD) to both eyes
• Placebo Comparator: Placebo BID
  Placebo administered twice daily (BID) to both eyes

Primary Outcome Measure

Percentage of study eyes with elimination of collarettes [ Time Frame: 6 weeks ]

Central Contacts

• Study Manager
  949-739-8749
  [email protected]

Locations (1)

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