Clinical trial NCT06249152: Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients
Official title: A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma (OAG)
Ocular Hypertension (OHT)
Glaucoma
Keywords: Qlaris
OAG
Glaucoma
PGA therapy
Apteryx I
OHT
latanoprost
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
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 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.
Primary purpose: TREATMENT

Brief summary: Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.

Detailed description: Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

Eligibility criteria: Inclusion Criteria:

* 12 years or older
* Able and willing provide signed informed consent (assent)
* mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., \>20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
* IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization

Exclusion Criteria:

* History of active ocular disease other than mild to moderate OAG/OHT
* Nonresponse to and/or noncompliant with PGA treatment
* Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
* Moderate to severe glaucomatous damage in either eye
* Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
* significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
* Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
* Clinically significant retinal disease in either eye
* Clinically significant systemic or psychiatric disease
* Participation in any investigational study within 30 days prior to screening
* Pregnant or lactating

Primary outcomes:
measure: Incidence of ocular treatment-emergent adverse events (TEAEs)
timeFrame: 28 days
measure: Clinically significant change in visual acuity
timeFrame: 28 days
measure: Clinically significant change in findings on slit lamp exam
timeFrame: 28 days
measure: Clinically significant change in findings on fundus exam
timeFrame: 28 days
measure: Incidence of systemic (TEAEs)
timeFrame: 28 days
measure: Clinically significant change in blood pressure
timeFrame: 28 days
measure: Clinically significant change in heart rate
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline (CFB) of mean diurnal IOP in the study eye
timeFrame: 28 days
measure: CFB in IOP at various timepoints in the study eye
timeFrame: 28 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Qlaris Bio, Inc.
name: Lisa Brandano
role: STUDY_DIRECTOR
References: