Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLK-321 low dose BID, GLK-321 low dose, GLK-321 mid dose BID, GLK-321 mid dose
GLK-321 · 1 trial · 1 indication
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 ...