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

• Sponsor: Qlaris Bio, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04830397
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 4
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension	Drug: QLS-101; Drug: Timolol Maleate	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 31, 2021
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Feb 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QLS-101 0.5%	Drug: QLS-101; Ophthalmic solution 1x daily
Experimental: QLS-101 1%	Drug: QLS-101; Ophthalmic solution 1x daily
Experimental: QLS-101 2%	Drug: QLS-101; Ophthalmic solution 1x daily
Active Comparator: Timolol Maleate 0.5% preservative free ophthalmic solution	Drug: Timolol Maleate; Ophthalmic solution 1x daily

Outcome Measures

Primary Outcome Measures

1. Ocular safety [100 days]

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

Secondary Outcome Measures

1. Ocular hypotensive efficacy [28 days]

   Number of participants with intraocular pressure reduction from baseline will be calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dixon Eye Care	Albany	Georgia	United States	31701

Sponsors and Collaborators

• Qlaris Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qlaris Bio, Inc.
• ClinicalTrials.gov Identifier: NCT04830397
• Other Study ID Numbers: QC-201
• First Posted: Apr 5, 2021
• Last Update Posted: May 6, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qlaris Bio, Inc.: elevated intraocular pressure
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Timolol

Study Results

No Results Posted as of May 6, 2022