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

Last updated: August 25, 2025
Sponsor: Qlaris Bio, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Glaucoma

Treatment

QLS-111 ophthalmic solution, (0.015%)

QLS-111 ophthalmic vehicle solution

QLS-111 ophthalmic solution (0.015%)

Clinical Study ID

NCT06030193
QC-111-202
Nightingale
  • Ages > 30
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofVisit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye

Exclusion

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 ocularhypotensive medications

  • Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes,cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if doneno earlier than 1 year from study, some minimally invasive glaucoma surgeries areallowed if done no earlier than 1.5 years from study)

  • Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis ofeye

  • 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 previousenrollment and treatment with Qlaris investigational product

  • Pregnant or lactating

Study Design

Total Participants: 36
Treatment Group(s): 5
Primary Treatment: QLS-111 ophthalmic solution, (0.015%)
Phase: 2
Study Start date:
August 13, 2025
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • To be determined

    Seoul,
    Korea, Republic of

    Site Not Available

  • To be determined

    Manila,
    Philippines

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 3080
    South Korea

    Active - Recruiting

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