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

Glaukos

Status and phase: Enrolling; Phase 2

Conditions: Demodex Blepharitis

Treatments: Drug: Placebo BID; Drug: GLK-321 high dose BID; Drug: GLK-321 low dose BID; Drug: GLK-321 high dose QD; Drug: GLK-321 mid dose BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT07400965

GLK-321-01

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups, including a placebo group

GLK-321 low dose BID

Experimental group

Description:

Low dose of GLK-321 administered twice daily (BID) to both eyes

Treatment:

Drug: GLK-321 low dose BID

GLK-321 mid dose BID

Experimental group

Description:

Mid dose of GLK-321 administered twice daily (BID) to both eyes

Treatment:

Drug: GLK-321 mid dose BID

GLK-321 high dose BID

Experimental group

Description:

High dose of GLK-321 administered twice daily (BID) to both eyes

Treatment:

Drug: GLK-321 high dose BID

GLK-321 high dose QD

Experimental group

Description:

High dose of GLK-321 administered once daily (QD) to both eyes

Treatment:

Drug: GLK-321 high dose QD

Placebo BID

Placebo Comparator group

Description:

Placebo administered twice daily (BID) to both eyes

Treatment:

Drug: Placebo BID