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Completed

NCT Number: NCT04857827

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

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Key information

Conditions

Normal Tension Glaucoma (NTG) Eye Diseases Glaucoma Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

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

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

Treatment and study plan

QLS-101

Drug

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

Other names: QLS-101 ophthalmic solution

Timolol maleate PF 0.5% ophthalmic solution

Drug

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

Other names: Timolol

Primary outcomes

  1. Ocular safety

    Time frame: 86 days

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

Secondary outcomes

  1. Ocular hypotensive efficacy

    Time frame: 14 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 Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
Jan 20, 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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