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Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).
Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% QLS-101 | Experimental | dosed once a day for 14 days as either first or second dosing period per randomization |
|
| 2% QLS-101 | Experimental | dosed once a day for 14 as either first or second dosing period per randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS-101ophthalmic solution 1% | Drug | QLS-101ophthalmic solution 1.0% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular adverse events (AEs) | Standard safety endpoint, ocular AEs, (including elevated IOP) | 56 days, including a 14-day washout |
| Visual acuity | Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline | 56 days, including a 14-day washout |
| Enhance depth imaging optical coherence tomography (EDI-OCT) | Standard safety endpoint, EDI-OCT, corneal thickness | 56 days, including a 14-day washout |
| Slit lamp exam | Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline | 56 days, including a 14-day washout |
| Dilated fundus exam | Fundus exam, abnormalities, changes from baseline | 56 days, including a 14-day washout |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular hypotensive efficacy | Mean change in IOP from baseline following 14 days dosing | 14 days after each dosing timepoint is completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B. Wirostko, M.D. | Qlaris Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| Qlaris Bio website, pipeline page | View source |
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| ID | Term |
|---|---|
| D013341 | Sturge-Weber Syndrome |
| D005901 | Glaucoma |
| D006871 | Hydrophthalmos |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
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Masked investigational product labeling.
| QLS-101ophthalmic solution 2% | Drug | QLS-101ophthalmic solution 2.0% |
|
|
| D020752 |
| Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005128 | Eye Diseases |
| D005124 | Eye Abnormalities |
| D005902 | Glaucoma, Open-Angle |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |