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

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)

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

Study Overview

• Status: Completed
• Conditions: Glaucoma; Normal Tension Glaucoma (NTG); Low-Tension Glaucoma, Bilateral; Low-Tension Glaucoma, Unspecified Eye
• Intervention / Treatment: Drug: QLS-111 ophthalmic solution (0.015%); Drug: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 3080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS-111 ophthalmic solution; Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.	Drug: 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.; Other Names: QLS-111
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.	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.; Other Names: Timolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)	Ocular safety and tolerability: (AEs)	14 days
Clinically significant change in visual acuity	Ocular safety and tolerability: visual acuity	14 days
Clinically significant change in findings on slit lamp exam	Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline	14 days
Clinically significant change in findings on fundus exam	Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye	14 days
Incidence of systemic TEAEs	Systemic safety and tolerability: AEs	14 days
Clinically significant changes in blood pressure (BP)	Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure	14 days
Clinically significant changes in heart rate (HR)	Systemic safety and tolerability: vital signs	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye	Ocular hypotensive efficacy: diurnal IOP CFB	14 days
CFB in IOP at various timepoints in the study eye	Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day	14 days

Collaborators and Investigators

• Sponsor: Qlaris Bio, Inc.
• Investigators: Study Director: Lisa Brandano, Qlaris Bio, Inc.

Publications and helpful links

Helpful Links

• Company website, pipeline

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): March 23, 2026

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Glaucoma; intraocular pressure (IOP); Qlaris; NTG; Nightingale; low-tension glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Optic Nerve Diseases; Ocular Hypertension; Glaucoma; Low Tension Glaucoma; Pharmaceutical Solutions; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Thiazoles; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Amines; Solutions; Specialty Uses of Chemicals; Alcohols; Propanolamines; Amino Alcohols; Propanols; Thiadiazoles; Morpholines; Oxazines; Ophthalmic Solutions; Timolol
• Other Study ID Numbers: QC-111-202; Nightingale (Other Identifier: Qlaris Bio, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No