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

March 27, 2023 updated by: Qlaris Bio, Inc.

A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision

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. 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QLS-101 ophthalmic solution 1.0%
Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
Drug: QLS-101
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Other Names:
  • QLS-101 ophthalmic solution
Active Comparator: Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Drug: Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Other Names:
  • Timolol
Experimental: QLS-101 ophthalmic solution 2.0%
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Drug: QLS-101
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Other Names:
  • QLS-101 ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular safety
Time Frame: 86 days
Number of participants with treatment-related adverse events will be monitored
86 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular hypotensive efficacy
Time Frame: 14 days
Number of participants with intraocular pressure reduction from baseline will be calculated
14 days

Collaborators and Investigators

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

Sponsor

Qlaris Bio, Inc.

Investigators

  • Study Director: B. Wirostko, M.D., 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)

September 15, 2021

Primary Completion (Actual)

August 26, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QC-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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