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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04830397

Enrollment

Registered

2021-04-05

Start date

2021-03-31

Completion date

2022-02-17

Last updated

2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma, Ocular Hypertension

Keywords

elevated intraocular pressure

Brief summary

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

Detailed description

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

Interventions

DRUGQLS-101

Ophthalmic solution 1x daily

DRUGTimolol Maleate

Ophthalmic solution 1x daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. Severe glaucomatous damage 2. Previous glaucoma intraocular or laser surgery 3. Refractive surgery 4. Ocular infection or inflammation

Design outcomes

Primary

Measure	Time frame	Description
Ocular safety	100 days	Number of participants with treatment-related adverse events will be monitored

Secondary

Measure	Time frame	Description
Ocular hypotensive efficacy	28 days	Number of participants with intraocular pressure reduction from baseline will be calculated.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026