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Completed

NCT Number: NCT07082816

Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

This study is designed to see how safe and effective a new eye drop, called Reformulated PG324, is for lowering eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trinity Research Group, Dothan, Alabama, United States

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About this study

About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension in both eyes;
  • Unmedicated intraocular pressure measurements in the study eye as specified in the protocol;
  • Corrected distance visual acuity equal to or better than 20/100 in the study eye.

Key Exclusion Criteria:

  • Current use of more than 2 ocular hypotensive medications within 30 days;
  • Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening;
  • Use of topical ocular medication of any kind within 5 days of Screening or throughout the study with the exception of ocular hypotensive medications (must be washed out).

Treatment and study plan

Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

Drug

Investigational ophthalmic solution

Other names: Reformulated PG324

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution

Drug

Commercially available ophthalmic solution

Other names: PG324, Rocklatan®

Primary outcomes

  1. Mean Intraocular Pressure at each timepoint post-randomization

    Time frame: Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint.

Secondary outcomes

  1. Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy

    Time frame: Up to Month 3/study exit

    The subject will undergo a slit lamp examination at all visits, except for dispensing visits. The presence of moderate to severe conjunctival hyperemia (redness) will be recorded.

  2. Proportion of subjects with conjunctival hyperemia adverse events

    Time frame: Up to Month 3/study exit

    Occurrences of conjunctival hyperemia (redness) adverse events, either subject or investigator reported, will be recorded at each visit.

  3. Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization

    Time frame: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint.

  4. Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization

    Time frame: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

    Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint.

  5. Mean TSS-IOP scores at Month 3

    Time frame: Month 3

    The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered.

  6. Mean Changes in TSS-IOP scores from Screening to Month 3

    Time frame: Month 3

    The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Phase III, Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel Group Comparison Study Assessing the Ocular Hypotensive Efficacy of Reformulated PG324 Ophthalmic Solution in Subjects With Elevated Intraocular Pressure

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Apr 21, 2026

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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