Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Nightingale | Other Identifier | Qlaris Bio, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol).
Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS-111 ophthalmic solution | Experimental | Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF. |
|
| Timolol maleate PF 0.5% Ophthalmic Solution | Active Comparator | Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS-111 ophthalmic solution (0.015%) | Drug | QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-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: (AEs) | 14 days |
| Clinically significant change in visual acuity | Ocular safety and tolerability: visual acuity | 14 days |
| Clinically significant change in findings on slit lamp exam | Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline | 14 days |
| Clinically significant change in findings on fundus exam | Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye | 14 days |
| Incidence of systemic TEAEs | Systemic safety and tolerability: AEs | 14 days |
| Clinically significant changes in blood pressure (BP) | Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure | 14 days |
| Clinically significant changes in heart rate (HR) | Systemic safety and tolerability: vital signs | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye | Ocular hypotensive efficacy: diurnal IOP CFB | 14 days |
| CFB in IOP at various timepoints in the study eye | Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Brandano | Qlaris Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 3080 | South Korea |
Not provided
| Label | URL |
|---|---|
| Company website, pipeline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multi site double masked, active-controlled, randomized, prospective parallel, pilot study of 7 days' QPM dosing, followed by 7 days' BID dosing (7 days of dosing per regimen [14-day treatment period]) of an investigational product (IP), QLS-111 or Timolol. Both eyes (OU) will be dosed.
Not provided
Not provided
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 appearing packaging. Unmasked statistician preparing the masked randomization schedule.
|
| Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) | Drug | Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials. |
|
|
| 14 days |
| ID | Term |
|---|---|
| D057066 | Low Tension Glaucoma |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
Not provided
Not provided