Clinical trial NCT06441643: Next Generation Rocklatan
Official title: A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
IOP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Detailed description: During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Eligibility criteria: Stage 1 Key Inclusion Criteria;

* Diagnosis of OAG or OHT in both eyes.
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
* Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

* Diagnosis of OAG or OHT in both eyes.
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
* Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

* Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
* Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
* Glaucoma other than OAG.
* Previous glaucoma surgery.
* Any abnormality preventing reliable measurements.
* Unable to demonstrate proper eyedrop instillation.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean diurnal IOP at Day 8 (Stage 1)
timeFrame: Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean diurnal IOP at Day 29 (Stage 2)
timeFrame: Day 29 (8:00, 10:00, 16:00)
Secondary outcomes:
measure: Mean IOP at each post-treatment timepoint (Stage 1)
timeFrame: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
timeFrame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
timeFrame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
timeFrame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
timeFrame: Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
measure: Mean IOP at each post-treatment timepoint (Stage 2)
timeFrame: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
measure: Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
timeFrame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
measure: Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
timeFrame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
measure: Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
timeFrame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
measure: Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
timeFrame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Winston-Salem
country: United States
facility: James D. Branch Ophthalmology
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References: