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

NCT04857827 | Completed Phase 2 FDA Drug

• 1 other identifier: QC-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Tension Glaucoma (NTG)

Keywords

low tension glaucoma (LTG); glaucoma

Outcome Measures

Primary Outcomes (1)

• Ocular safety

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

  86 days

Secondary Outcomes (1)

• Ocular hypotensive efficacy

  14 days

Study Arms (3)

QLS-101 ophthalmic solution 1.0%

EXPERIMENTAL

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

Timolol maleate PF 0.5% ophthalmic solution

ACTIVE COMPARATOR

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

Drug: Timolol maleate PF 0.5% ophthalmic solution

QLS-101 ophthalmic solution 2.0%

EXPERIMENTAL

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

Drug: QLS-101

Interventions

QLS-101 DRUG

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

Also known as: QLS-101 ophthalmic solution

QLS-101 ophthalmic solution 1.0%; QLS-101 ophthalmic solution 2.0%

Timolol maleate PF 0.5% ophthalmic solution DRUG

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

Also known as: Timolol

Timolol maleate PF 0.5% ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Related Links

• company website

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma

Interventions

Ophthalmic Solutions; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• B. Wirostko, M.D.

  Qlaris Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: September 15, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)