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CompletedNCT06441643Updated Nov 18, 2025

Next Generation Rocklatan

A Phase 2 interventional study of AR-17043 Ophthalmic Solution and PG043 Ophthalmic Solution in Open Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Alcon Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Open Angle Glaucoma
  • Ocular Hypertension

Keywords

  • Glaucoma
  • IOP
03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 426 is above the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
426 participants (actual)

Study 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.

    Drug: AR-17043 Ophthalmic Solution

  • 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.

    Drug: AR-17043 Ophthalmic Solution

  • 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.

    Drug: AR-17043 Ophthalmic Solution

  • 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.

    Drug: AR-17043 Vehicle

  • 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.

    Drug: Netarsudil 0.02% Ophthalmic Solution

  • Experimental
    PG043 low concentration (Stage 2)

    PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

    Drug: PG043 Ophthalmic Solution

  • Experimental
    PG043 high concentration (Stage 2)

    PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

    Drug: PG043 Ophthalmic Solution

  • Active comparator
    AR-17043 high concentration (Stage 2)

    AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

    Drug: AR-17043 Ophthalmic Solution

  • Active comparator
    Latanoprost (Stage 2)

    Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

    Drug: Latanoprost 0.005% Ophthalmic Solution

  • 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.

    Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Interventions

  • DrugAR-17043 Ophthalmic Solution

    Investigational monotherapy supplied in three concentration levels: low, medium, high

  • DrugPG043 Ophthalmic Solution

    Investigational fixed dose combination supplied in two concentration levels: low and high

  • DrugLatanoprost 0.005% Ophthalmic Solution

    Marketed monotherapy

    Also known as: Latanoprost

  • DrugNetarsudil 0.02% Ophthalmic Solution

    Marketed monotherapy

    Also known as: Rhopressa®

  • DrugNetarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

    Marketed fixed dose combination

    Also known as: Rocklatan®

  • DrugAR-17043 Vehicle

    Placebo comparator

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

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

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

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

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. 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.

    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)

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

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

    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)

  7. 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.

    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)

  8. 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.

    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)

  9. 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.

    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)

  10. 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.

    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)

07

Study locations

12 sites
  • Orange County Ophthalmology Medical Group
    Garden Grove, California 92843, United States
  • United Medical Research Institute
    Inglewood, California 90301, United States
  • Eye Research Foundation
    Newport Beach, California 92663, United States
  • North Bay Eye Associates
    Petaluma, California 94954, United States
  • Eye Center of Northern Colorado, PC
    Fort Collins, Colorado 80528, United States
  • Coastal Research Associates
    Roswell, Georgia 30076, United States
  • Rochester Ophthalmological Group
    Rochester, New York 14618, United States
  • James D. Branch Ophthalmology
    Winston-Salem, North Carolina 27101, United States
  • Scott & Christie and Associates, PC
    Cranberry Township, Pennsylvania 16066, United States
  • University Eye Specialists
    Maryville, Tennessee 37803, United States
  • Total Eye Care PA
    Memphis, Tennessee 38119, United States
  • Piedmont Eye Center
    Lynchburg, Virginia 24502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06441643
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Sep 4, 2024
Primary completion
Nov 14, 2025
Completion
Nov 14, 2025
Last update
Nov 18, 2025

Study contacts

Clinical Trial Lead, Pharma
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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