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A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS-101 ophthalmic solution 1.0% | Experimental | Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing. |
|
| Timolol maleate PF 0.5% ophthalmic solution | Active Comparator | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
|
| QLS-101 ophthalmic solution 2.0% | Experimental | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS-101 | Drug | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety | Number of participants with treatment-related adverse events will be monitored | 86 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular hypotensive efficacy | Number of participants with intraocular pressure reduction from baseline will be calculated | 14 days |
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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 |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
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| Label | URL |
|---|---|
| company website | View source |
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| ID | Term |
|---|---|
| D057066 | Low Tension Glaucoma |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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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 investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.
|
| Timolol maleate PF 0.5% ophthalmic solution | Drug | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
|
|
| 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 |