Next Generation Rocklatan

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Sep 4, 2024

Status verified

Nov 2025

Primary completion

Nov 14, 2025

Completion

Nov 14, 2025

Study Design

Enrollment

426 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AR-17043 low concentration (Stage 1)
  AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
• Experimental: AR-17043 medium concentration (Stage 1)
  AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
• Experimental: AR-17043 high concentration (Stage 1)
  AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
• Placebo Comparator: AR-17043 vehicle (Stage 1)
  AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
• Active Comparator: Rhopressa (Stage 1)
  Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
• Experimental: PG043 low concentration (Stage 2)
  PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
• Experimental: PG043 high concentration (Stage 2)
  PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
• Active Comparator: AR-17043 high concentration (Stage 2)
  AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
• Active Comparator: Latanoprost (Stage 2)
  Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
• Active Comparator: Rocklatan (Stage 2)
  Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Primary Outcome Measure

Mean diurnal IOP at Day 8 (Stage 1) [ Time Frame: Day 8 (8:00, 10:00, 12:00, 16:00) ]

Locations (12)

Find similar trials in Garden Grove, CA

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