Ocular HypertensionPhase 3NCT07082816
Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction
A Phase 3 study testing Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution and Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in people with Ocular Hypertension and Open Angle Glaucoma, run by Alcon Research at 30 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution and Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 30 sitesUnited States
- Study dates
- 2 Sep 2025to 6 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Midwest Eye Center
Cincinnati, Ohio, 45236
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Coldwater Vision Research
Coldwater, Mississippi, 38618
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Central Florida Eye Specialists
DeLand, Florida, 32720
Glaucoma Specialists of South Florida
Delray Beach, Florida, 33484
Trinity Research Group
Dothan, Alabama, 36301
Albemarle Eye Center
Elizabeth City, North Carolina, 27909
North Georgia Eye Associates
Gainesville, Georgia, 30501
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Oculus Research, Inc.
Garner, North Carolina, 27529
Las Vegas Eye Institute
Henderson, Nevada, 89052
United Medical Research Institute
Inglewood, California, 90301
East Coast Institute for Research, LLC
Jacksonville, Florida, 32256
Central Florida Eye Associates
Lakeland, Florida, 33805
The Eye Institute of West Florida
Largo, Florida, 33770
Lee Shettle Eye
Largo, Florida, 33773
Piedmont Eye Center
Lynchburg, Virginia, 24502
Southern College of Optometry
Memphis, Tennessee, 38104
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Eye Doctors of Arizona
Phoenix, Arizona, 85028
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
Rochester Ophthalmological Group
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
Sacramento Eye Consultants
Sacramento, California, 95815
The Eye Institute of Utah
Salt Lake City, Utah, 84107
CORE, Inc.
Shelby, North Carolina, 28150
NorthEast Eye Research Associates, LLC
Westborough, Massachusetts, 01581
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution, Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution
- Keywords
- Glaucoma, OAG, OHT
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil 0.01%/latanoprost 0.005% ophthalmic solutionDrug
Also called Reformulated PG324
Investigational ophthalmic solution
Netarsudil 0.02%/latanoprost 0.005% ophthalmic solutionDrug
Also called PG324, Rocklatan®
Commercially available ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Reformulated PG324 | Experimental | One drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months Receives: Drug: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution |
| PG324 | Active comparator | One drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months Receives: Drug: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure at each timepoint post-randomization
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.
Measured: Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Secondary outcomes (6)
Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy
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.
Measured: Up to Month 3/study exit
Proportion of subjects with conjunctival hyperemia adverse events
Occurrences of conjunctival hyperemia (redness) adverse events, either subject or investigator reported, will be recorded at each visit.
Measured: Up to Month 3/study exit
Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization
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.
Measured: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization
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.
Measured: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Mean TSS-IOP scores at 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.
Measured: Month 3
Mean Changes in TSS-IOP scores from Screening to 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start2 Sep 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082816
- Sponsor's protocol ID
- GLR749-C001
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07082816
- Acronym / sponsor ID
- GLR749-C001
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- Glaucoma, OAG, OHT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reformulated PG324 | Experimental | Drug: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solutionOne drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months |
| PG324 | Active comparator | Drug: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solutionOne drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netarsudil 0.01%/latanoprost 0.005% ophthalmic solutionAlso: Reformulated PG324Investigational ophthalmic solution | Drug | Reformulated PG324 |
| Netarsudil 0.02%/latanoprost 0.005% ophthalmic solutionAlso: PG324, Rocklatan®Commercially available ophthalmic solution | Drug | PG324 |
Primary outcome
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.
6 secondary outcomes
Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy
Time frame: Up to Month 3/study exit
Proportion of subjects with conjunctival hyperemia adverse events
Time frame: Up to Month 3/study exit
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
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
Mean TSS-IOP scores at Month 3
Time frame: Month 3
Mean Changes in TSS-IOP scores from Screening to Month 3
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Pharma study director
Alcon Research, LLC
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution and Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in people with Ocular Hypertension and Open Angle Glaucoma, run by Alcon Research at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intraocular Pressure at each timepoint post-randomization (time frame: Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.