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Clinical trial

A Randomized Active-controlled Multi-site Double-masked 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

ID
Name
QC-201
Description
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.
Trial arms
Trial start
2021-03-31
Estimated PCD
2022-02-17
Trial end
2022-02-17
Status
Completed
Phase
Early phase I
Treatment
QLS-101
Ophthalmic solution 1x daily
Arms:
QLS-101 0.5%, QLS-101 1%, QLS-101 2%
Timolol Maleate
Ophthalmic solution 1x daily
Arms:
Timolol Maleate 0.5% preservative free ophthalmic solution
Size
84
Primary endpoint
Ocular safety
100 days
Eligibility criteria
Inclusion Criteria: 1. Visual acuity +1.0 logMAR or better 2. Willing to give informed consent 3. Ability to washout from current intraocular pressure lowering medications - Exclusion Criteria: 1. Severe glaucomatous damage 2. Previous glaucoma intraocular or laser surgery 3. Refractive surgery 4. Ocular infection or inflammation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}
Updated at
2023-03-17

1 organization

2 products

2 indications

Organization
Qlaris Bio
Product
QLS-101
Indication
Primary Open Angle Glaucoma
Indication
ocular hypertension
Product
Timolol Maleate