Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

Qlaris Bio, Inc.84 enrolled

Overview

Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

QLS-101DRUG

Ophthalmic solution 1x daily

Timolol MaleateDRUG

Ophthalmic solution 1x daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dixon Eye Care

Albany, Georgia, United States

Outcomes

Primary Outcomes

Ocular safety

Number of participants with treatment-related adverse events will be monitored

Time frame: 100 days

Secondary Outcomes

Ocular hypotensive efficacy

Number of participants with intraocular pressure reduction from baseline will be calculated.

Time frame: 28 days

Data from ClinicalTrials.gov

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