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Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS-101, 2.0% | Experimental | Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS-101 ophthalmic solution, 2.0 % | Drug | ophthalmic solution in a single use dropper vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety | Incidence of ocular treatment emergent adverse events (TEAEs) | Over 28 days |
| Systemic safety | Incidence of systemic TEAEs | Over 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular hypotensive effectiveness | Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101 | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Freedman, M.D. | Duke Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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Open-label, single treatment
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| ID | Term |
|---|---|
| D013341 | Sturge-Weber Syndrome |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005128 | Eye Diseases |
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