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OpenTrials
Completed

NCT Number: NCT06441643

Next Generation Rocklatan

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).

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orange County Ophthalmology Medical Group, Garden Grove, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Latanoprost

Netarsudil 0.02% Ophthalmic Solution

Drug

Marketed monotherapy

Other names: Rhopressa®

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution

Drug

Marketed fixed dose combination

Other names: Rocklatan®

AR-17043 Vehicle

Drug

Placebo comparator

Primary outcomes

  1. Mean diurnal IOP at Day 8 (Stage 1)

    Time frame: Day 8 (8:00, 10:00, 12:00, 16:00)

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.

  2. Mean diurnal IOP at Day 29 (Stage 2)

    Time frame: Day 29 (8:00, 10:00, 16:00)

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.

Secondary outcomes

  1. Mean IOP at each post-treatment timepoint (Stage 1)

    Time frame: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.

  2. Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)

    Time frame: 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)

    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.

  3. Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)

    Time frame: 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)

    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.

  4. Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)

    Time frame: 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)

    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.

  5. Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)

    Time frame: 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)

    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.

  6. Mean IOP at each post-treatment timepoint (Stage 2)

    Time frame: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.

  7. Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)

    Time frame: 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)

    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.

  8. Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)

    Time frame: 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)

    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.

  9. Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)

    Time frame: 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)

    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.

  10. Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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