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

NCT ID: NCT04857827

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-08-26

Brief Summary

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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

Detailed Description

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Conditions

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Normal Tension Glaucoma (NTG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

QLS-101

Intervention Type DRUG

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

Timolol maleate PF 0.5% ophthalmic solution

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

Group Type ACTIVE_COMPARATOR

Timolol maleate PF 0.5% ophthalmic solution

Intervention Type DRUG

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

QLS-101 ophthalmic solution 2.0%

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

Group Type EXPERIMENTAL

QLS-101

Intervention Type DRUG

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

Interventions

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QLS-101

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

Intervention Type DRUG

Timolol maleate PF 0.5% ophthalmic solution

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

Intervention Type DRUG

Other Intervention Names

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QLS-101 ophthalmic solution Timolol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qlaris Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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B. Wirostko, M.D.

Role: STUDY_DIRECTOR

Qlaris Bio, Inc.

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Related Links

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https://qlaris.bio

company website

Other Identifiers

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QC-202

Identifier Type: -

Identifier Source: org_study_id

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