Next Generation Rocklatan

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441643
• Other study ID #: GLR305-E001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
• PG043 Ophthalmic Solution
Investigational fixed dose combination supplied in two concentration levels: low and high
• Latanoprost 0.005% Ophthalmic Solution
Marketed monotherapy
• Netarsudil 0.02% Ophthalmic Solution
Marketed monotherapy
• Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Marketed fixed dose combination
• AR-17043 Vehicle
Placebo comparator

Locations

Country	Name	City	State
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Eye Center of Northern Colorado, PC	Fort Collins	Colorado
United States	United Medical Research Institute	Inglewood	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	University Eye Specialists	Maryville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Coastal Research Associates	Roswell	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal IOP at Day 8 (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.	Day 8 (8:00, 10:00, 12:00, 16:00)
Primary	Mean diurnal IOP at Day 29 (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.	Day 29 (8:00, 10:00, 16:00)
Secondary	Mean IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.	Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Secondary	Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.	Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Secondary	Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	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)
Secondary	Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	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)