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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLK-321 low dose BID | Experimental | Low dose of GLK-321 administered twice daily (BID) to both eyes |
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| GLK-321 mid dose BID | Experimental | Mid dose of GLK-321 administered twice daily (BID) to both eyes |
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| GLK-321 high dose BID | Experimental | High dose of GLK-321 administered twice daily (BID) to both eyes |
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| GLK-321 high dose QD | Experimental | High dose of GLK-321 administered once daily (QD) to both eyes |
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| Placebo BID | Placebo Comparator | Placebo administered twice daily (BID) to both eyes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLK-321 low dose BID | Drug | Twice daily administration of low dose GLK-321 to both eyes |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of study eyes with elimination of collarettes | 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 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Contact | 949-739-8749 | ClinicalResearch@Glaukos.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director, MD | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Clinical Study Site | Recruiting | Newport Beach | California | 92663 | United States |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| GLK-321 mid dose BID | Drug | Twice daily administration of mid dose GLK-321 to both eyes |
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| GLK-321 high dose BID | Drug | Twice daily administration of high dose GLK-321 to both eyes |
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| GLK-321 high dose QD | Drug | Once daily administration of high dose GLK-321 to both eyes |
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| Placebo BID | Drug | Twice daily administration of placebo to both eyes |
|