Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
Phase 2
Completed
- Conditions
- Ocular HypertensionPrimary Open Angle Glaucoma
- Interventions
- Registration Number
- NCT04830397
- Lead Sponsor
- Qlaris Bio, Inc.
- Brief Summary
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.
- Detailed Description
Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
Exclusion Criteria
- Severe glaucomatous damage
- Previous glaucoma intraocular or laser surgery
- Refractive surgery
- Ocular infection or inflammation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QLS-101 1% QLS-101 - QLS-101 0.5% QLS-101 - Timolol Maleate 0.5% preservative free ophthalmic solution Timolol Maleate - QLS-101 2% QLS-101 -
- Primary Outcome Measures
Name Time Method Ocular safety 100 days Number of participants with treatment-related adverse events will be monitored
- Secondary Outcome Measures
Name Time Method Ocular hypotensive efficacy 28 days Number of participants with intraocular pressure reduction from baseline will be calculated.
Trial Locations
- Locations (1)
Dixon Eye Care
🇺🇸Albany, Georgia, United States
Dixon Eye Care🇺🇸Albany, Georgia, United States