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OpenTrials
Completed

NCT Number: NCT04830397

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

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

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dixon Eye Care

Albany, Georgia, 31701, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Visual acuity +1.0 logMAR or better
  • Willing to give informed consent
  • Ability to washout from current intraocular pressure lowering medications -

Exclusion criteria

  • Severe glaucomatous damage
  • Previous glaucoma intraocular or laser surgery
  • Refractive surgery
  • Ocular infection or inflammation

Treatment and study plan

QLS-101

Drug

Ophthalmic solution 1x daily

timolol maleate

Drug

Ophthalmic solution 1x daily

Primary outcomes

  1. Ocular safety

    Time frame: 100 days

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

Secondary outcomes

  1. Ocular hypotensive efficacy

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Qlaris Bio, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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