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

NCT ID: NCT04830397

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-02-17

Brief Summary

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

Detailed Description

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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

Conditions

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Primary Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QLS-101 0.5%

Group Type EXPERIMENTAL

QLS-101

Intervention Type DRUG

Ophthalmic solution 1x daily

QLS-101 1%

Group Type EXPERIMENTAL

QLS-101

Intervention Type DRUG

Ophthalmic solution 1x daily

QLS-101 2%

Group Type EXPERIMENTAL

QLS-101

Intervention Type DRUG

Ophthalmic solution 1x daily

Timolol Maleate 0.5% preservative free ophthalmic solution

Group Type ACTIVE_COMPARATOR

Timolol Maleate

Intervention Type DRUG

Ophthalmic solution 1x daily

Interventions

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QLS-101

Ophthalmic solution 1x daily

Intervention Type DRUG

Timolol Maleate

Ophthalmic solution 1x daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qlaris Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dixon Eye Care

Albany, Georgia, United States

Site Status

Countries

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United States

Related Links

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https://qlaris.bio

Company website, pipeline

Other Identifiers

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QC-201

Identifier Type: -

Identifier Source: org_study_id

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