Clinical trial NCT06030193: Study of an Investigational Product, QLS-111, Provided as an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Normal Tension Glaucoma (NTG)
Low-Tension Glaucoma, Bilateral
Low-Tension Glaucoma, Unspecified Eye
Glaucoma
Keywords: NTG
Qlaris
intraocular pressure (IOP)
Glaucoma
Nightingale
low-tension glaucoma
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
timeFrame: 14 days
measure: Clinically significant change in visual acuity
timeFrame: 14 days
measure: Clinically significant change in findings on slit lamp exam
timeFrame: 14 days
measure: Clinically significant change in findings on fundus exam
timeFrame: 14 days
measure: Incidence of systemic TEAEs
timeFrame: 14 days
measure: Clinically significant changes in blood pressure (BP)
timeFrame: 14 days
measure: Clinically significant changes in heart rate (HR)
timeFrame: 14 days
Secondary outcomes:
measure: Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
timeFrame: 14 days
measure: CFB in IOP at various timepoints in the study eye
timeFrame: 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Qlaris Bio, Inc.
name: Lisa Brandano
role: STUDY_DIRECTOR
References: