Recruiting
Phase 2

GLK-321

Sponsor:

Glaukos Corporation

Code:

NCT07400965

Conditions

Demodex Blepharitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLK-321 low dose BID

GLK-321 mid dose BID

GLK-321 high dose BID

GLK-321 high dose QD

Placebo BID

Study Details

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.

Conditions

Demodex Blepharitis

Study ID

NCT07400965

Start date

Dec 5, 2025

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

GLK-321 low dose BID

Twice daily administration of low dose GLK-321 to both eyes

GLK-321 mid dose BID

Twice daily administration of mid dose GLK-321 to both eyes

GLK-321 high dose BID

Twice daily administration of high dose GLK-321 to both eyes

GLK-321 high dose QD

Once daily administration of high dose GLK-321 to both eyes

Placebo BID

Twice daily administration of placebo to both eyes

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Manager

949-739-8749ClinicalResearch@Glaukos.com

Locations

Glaukos Clinical Study Site

Recruiting

Newport Beach, California, United States, 92663

Contacts

Study Manager

949-739-8749ClinicalResearch@Glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • demodex blepharitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-02-27.