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

NCT06030193 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: QC-111-202Nightingale
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

NTG; Qlaris; intraocular pressure (IOP); Glaucoma; Nightingale; low-tension glaucoma

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye

  14 days

• CFB in IOP at various timepoints in the study eye

  14 days

Study Arms (2)

QLS-111 ophthalmic solution

EXPERIMENTAL

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

Drug: QLS-111 ophthalmic solution (0.015%)

Timolol maleate PF 0.5% Ophthalmic Solution

ACTIVE COMPARATOR

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)

Interventions

Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) 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.

Also known as: Timolol

Timolol maleate PF 0.5% Ophthalmic Solution

QLS-111 ophthalmic solution (0.015%) 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.

Also known as: QLS-111

QLS-111 ophthalmic solution

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Related Links

• Company website, pipeline

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma

Interventions

Ophthalmic Solutions; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Lisa Brandano

  Qlaris Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi site double masked, active-controlled, randomized, prospective parallel, pilot study of 7 days' QPM dosing, followed by 7 days' BID dosing (7 days of dosing per regimen \[14-day treatment period\]) of an investigational product (IP), QLS-111 or Timolol. Both eyes (OU) will be dosed.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 8, 2023
• Study Start: August 13, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)