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| ID | Type | Description | Link |
|---|---|---|---|
| Osprey | Other Identifier | Qlaris Bio, Inc. |
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Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS-111 ophthalmic solution | Experimental | Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF). |
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| QLS-111 ophthalmic vehicle solution | Placebo Comparator | Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: QLS-111 ophthalmic solution, (0.015%) | Drug | QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) | Ocular safety and tolerability: adverse events (AEs) | 21 days |
| Clinically significant change in visual acuity | Ocular safety and tolerability: visual acuity | 21 days |
| Clinically significant change in findings on slit lamp exam | Ocular safety and tolerability: slit lamp | 21 days |
| Clinically significant change in findings on fundus exam | Ocular safety and tolerability: fundus | 21 days |
| Incidence of systemic TEAEs | Systemic safety and tolerability: AEs | 21 days |
| Clinically significant changes in blood pressure (BP) | Systemic safety and tolerability: vital signs | 21 days |
| Clinically significant changes in heart rate (HR) | Systemic safety and tolerability: vital signs | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye | Ocular hypotensive efficacy: diurnal IOP CFB | 21 days |
| CFB in IOP at various timepoints in the study eye | Ocular hypotensive efficacy: CFB for multiple timepoints throughout day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Brandano | Qlaris Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
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| Label | URL |
|---|---|
| Company website, pipeline | View source |
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Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.
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Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical packaging. Unmasked statistician preparing the masked randomization schedule.
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| Experimental: QLS-111 ophthalmic solution, (0.03%) | Drug | QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. |
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| Experimental: QLS-111 ophthalmic solution, (0.075%) | Drug | QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. |
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| QLS-111 ophthalmic vehicle solution | Other | Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. |
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| up to 21 days |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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