A Randomized, Active-controlled, Multi-site, Double-masked, Pilot Study to Evaluate the Safety and Tolerability of QLS-111 Versus Timolol Maleate Preservative Free 0.5% Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• 30 years or older
• Able to provide written acknowledgement of giving informed consent
• Best corrected visual acuity (BCVA) 20/200 or better
• NTG in both eyes with untreated IOP \<21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP \<22 mmHg in either eye
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Lisa Brandano
lbrandano@qlaris.bio
9789302103
Backup
Daniel DeWalt
ddewalt@qlaris.bio
Time Frame
Start Date: 2025-08-13
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 36
Treatments
Experimental: QLS-111 ophthalmic solution
Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.
Active_comparator: Timolol maleate PF 0.5% Ophthalmic Solution
Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked.
Related Therapeutic Areas
Sponsors
Leads: Qlaris Bio, Inc.