Study of an Investigational Product, QLS-111, Provided as an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)

NCT ID: NCT06030193

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2025-12-30

Brief Summary

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.

Detailed Description

A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol).

Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.

Conditions

Normal Tension Glaucoma (NTG); Low-Tension Glaucoma, Bilateral; Low-Tension Glaucoma, Unspecified Eye; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QLS-111 ophthalmic solution

Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.

Group Type: EXPERIMENTAL

QLS-111 ophthalmic solution (0.015%)

Intervention Type: DRUG

QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials.

Timolol maleate PF 0.5% Ophthalmic Solution

Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked.

Group Type: ACTIVE_COMPARATOR

Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)

Intervention Type: DRUG

Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials.

Interventions

QLS-111 ophthalmic solution (0.015%)

QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials.

Intervention Type: DRUG

Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)

Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials.

Intervention Type: DRUG

Other Intervention Names

QLS-111; Timolol

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• History of angle closure glaucoma, narrow or occludable angle on gonioscope
• All secondary glaucomas
• Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
• Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1.5 years from study)
• Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
• Use of other ophthalmic concomitant medications during the study
• Refractive surgery
• Uncontrolled hypertension or hypotension
• Significant systemic or psychiatric disease
• Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
• Pregnant or lactating

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qlaris Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Brandano

Role: STUDY_DIRECTOR

Qlaris Bio, Inc.

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Lisa Brandano

Role: CONTACT

lbrandano@qlaris.bio

9789302103

Daniel DeWalt

Role: CONTACT

ddewalt@qlaris.bio

Related Links

https://qlaris.bio

Company website, pipeline

Other Identifiers

Nightingale

Identifier Type: OTHER

Identifier Source: secondary_id

QC-111-202

Identifier Type: -

Identifier Source: org_study_id