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

March 14, 2023 updated by: Qlaris Bio, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Albany, Georgia, United States, 31701
        • Dixon Eye Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QLS-101 0.5%
Drug: QLS-101
Ophthalmic solution 1x daily
Experimental: QLS-101 1%
Drug: QLS-101
Ophthalmic solution 1x daily
Experimental: QLS-101 2%
Drug: QLS-101
Ophthalmic solution 1x daily
Active Comparator: Timolol Maleate 0.5% preservative free ophthalmic solution
Drug: Timolol Maleate
Ophthalmic solution 1x daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular safety
Time Frame: 100 days
Number of participants with treatment-related adverse events will be monitored
100 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular hypotensive efficacy
Time Frame: 28 days
Number of participants with intraocular pressure reduction from baseline will be calculated.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qlaris Bio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QC-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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