A Study to Evaluate Safety and Tolerability of QLS-101 in NTG

Qlaris Bio, Inc.30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Normal Tension Glaucoma (NTG)

Interventions

QLS-101DRUG

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

Timolol maleate PF 0.5% ophthalmic solutionDRUG

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

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. All secondary glaucomas 2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening) 3. Refractive surgery 4. Ocular infection or inflammation

Locations (1)

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Ocular safety

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

Time frame: 86 days

Secondary Outcomes

Ocular hypotensive efficacy

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

Time frame: 14 days

Data from ClinicalTrials.gov

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