Clinical trial NCT06016972: Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
Official title: A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma (POAG)
Primary Open Angle Glaucoma of Both Eyes
Primary Open-Angle Glaucoma, Unspecified Eye
Ocular Hypertension (OHT)
Keywords: Qlaris
POAG
OHT
IOP
Glaucoma
Osprey
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen \[21-day treatment period\])of an investigational product (IP), QLS-111 or vehicle. 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 primary open-angle glaucoma (POAG) or ocular hypertension patients.

Detailed description: A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Able to provide written acknowledgement of giving informed consent
* Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
* Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2

Exclusion Criteria:

* IOP \>34 mmHg
* 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 year from study)
* Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
* Use of other ophthalmic concomitant medications during the study
* 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: 21 days
measure: Clinically significant change in visual acuity
timeFrame: 21 days
measure: Clinically significant change in findings on slit lamp exam
timeFrame: 21 days
measure: Clinically significant change in findings on fundus exam
timeFrame: 21 days
measure: Incidence of systemic TEAEs
timeFrame: 21 days
measure: Clinically significant changes in blood pressure (BP)
timeFrame: 21 days
measure: Clinically significant changes in heart rate (HR)
timeFrame: 21 days
Secondary outcomes:
measure: Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
timeFrame: 21 days
measure: CFB in IOP at various timepoints in the study eye
timeFrame: up to 21 days
Other outcomes:
Locations:
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
Study officials:
affiliation: Qlaris Bio, Inc.
name: Lisa Brandano
role: STUDY_DIRECTOR
References: