Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07400965 | Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis | PHASE2 | RECRUITING | 250 | — | — | Dec 5, 2025 | Nov 1, 2026 | Feb 27, 2026 | 1 | United States |
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
| Arm | Type | Description |
|---|---|---|
| GLK-321 low dose BID | EXPERIMENTAL | Low dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 mid dose BID | EXPERIMENTAL | Mid dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose BID | EXPERIMENTAL | High dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose QD | EXPERIMENTAL | High dose of GLK-321 administered once daily (QD) to both eyes |
| Placebo BID | PLACEBO_COMPARATOR | Placebo administered twice daily (BID) to both eyes |
| Name | Type | Description |
|---|---|---|
| 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 |
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 ...