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NCT04830397 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04830397
Other study ID # QC-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 31, 2021
Est. completion date February 17, 2022

Study information
Verified date April 2021
Source Qlaris Bio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date February 17, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QLS-101
Ophthalmic solution 1x daily
• Timolol Maleate
Ophthalmic solution 1x daily

Locations
Country Name City State
United States Dixon Eye Care Albany Georgia

Sponsors (1)
Lead Sponsor Collaborator
Qlaris Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular safety Number of participants with treatment-related adverse events will be monitored 100 days
Secondary Ocular hypotensive efficacy Number of participants with intraocular pressure reduction from baseline will be calculated. 28 days
See also
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Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
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