Open-angle GlaucomaPhase 3NCT02674854

Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

A Phase 3 study testing PG324 Ophthalmic Solution 0.02%/0.005%, Netarsudil (AR-13324) ophthalmic solution 0.02% and Latanoprost ophthalmic solution 0.005% in people with Open-angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005% Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: PG324 Ophthalmic Solution 0.02%/0.005%, Netarsudil (AR-13324) ophthalmic solution 0.02% and Latanoprost ophthalmic solution 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 1 siteUnited States
Study dates: Feb 2016to Mar 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older (19 years of age or older in Canada)
Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
Able to give informed consent and follow study instructions

Who cannot join

Ophthalmic:
Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation or latanoprost
Previous glaucoma surgery or refractive surgery

Show all 18Show fewer

Ocular trauma within 6 months prior to screening
Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
Recent or current ocular infection or inflammation in either eye
Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
Mean central corneal thickness >620µm at screening in either eye
Any abnormality preventing reliable applanation tonometry of either eye
Systemic:
Clinically significant abnormalities in lab tests at screening
Clinically significant systemic disease
Participation in any investigational study within 60 days prior to screening
Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Trial locations and contacts

1 site in 1 country.

United States1 site

Aerie Pharmaceuticals
Bedminster, New Jersey, 07921

Other trials in United States

About this study

Official title: A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: PG324 Ophthalmic Solution 0.02%/0.005%, Netarsudil (AR-13324) ophthalmic solution 0.02%, Latanoprost ophthalmic solution 0.005%
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PG324 Ophthalmic Solution 0.02%/0.005%Drug
1 drop daily in the evening (PM) in both eyes (OU)
Netarsudil (AR-13324) ophthalmic solution 0.02%Drug
1 drop daily in the evening (PM) in both eyes (OU)
Latanoprost ophthalmic solution 0.005%Drug
1 drop daily in the evening (PM) in both eyes (OU)

Study groups in NCT02674854
Study group	Role	What they receive
PG324 Ophthalmic Solution 0.02%/0.005%	Experimental	Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution Receives: Drug: PG324 Ophthalmic Solution 0.02%/0.005%
Netarsudil (AR-13324) ophthalmic solution 0.02%	Active comparator	Netarsudil 0.02% ophthalmic solution Receives: Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%
Latanoprost ophthalmic solution 0.005%	Active comparator	Latanoprost 0.005 % ophthalmic solution Receives: Drug: Latanoprost ophthalmic solution 0.005%

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP)
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Mar 2017

First posted5 Feb 2016 (estimated)
Study startFeb 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Open-angle GlaucomaStudies 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: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02674854
Sponsor's protocol ID: PG324-CS302
Status last verified: May 2019
First submitted: 1 Feb 2016
Last updated: 21 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.
PubMed 32166538
Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.
PubMed 31981106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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All Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
ClinicalTrials.gov ID: NCT02674854
Acronym / sponsor ID: PG324-CS302
Conditions: Open-angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 5 Feb 2016 (estimated)
Results: Posted 1 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
PG324 Ophthalmic Solution 0.02%/0.005%	Experimental	Drug: PG324 Ophthalmic Solution 0.02%/0.005%Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
Netarsudil (AR-13324) ophthalmic solution 0.02%	Active comparator	Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%Netarsudil 0.02% ophthalmic solution
Latanoprost ophthalmic solution 0.005%	Active comparator	Drug: Latanoprost ophthalmic solution 0.005%Latanoprost 0.005 % ophthalmic solution

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years of age or older (19 years of age or older in Canada)
Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
Able to give informed consent and follow study instructions

Key exclusion criteria (18 listed)

Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation or latanoprost
Previous glaucoma surgery or refractive surgery

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
PG324 Ophthalmic Solution 0.02%/0.005%1 drop daily in the evening (PM) in both eyes (OU)	Drug	PG324 Ophthalmic Solution 0.02%/0.005%
Netarsudil (AR-13324) ophthalmic solution 0.02%1 drop daily in the evening (PM) in both eyes (OU)	Drug	Netarsudil (AR-13324) ophthalmic solution 0.02%
Latanoprost ophthalmic solution 0.005%1 drop daily in the evening (PM) in both eyes (OU)	Drug	Latanoprost ophthalmic solution 0.005%

Primary outcome

Intraocular Pressure (IOP)
Time frame: 3 months
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.

Results and safety

Results posted to the registry on 1 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PG324 Ophthalmic Solution 0.02%/0.005%	245	221
Netarsudil (AR-13324) Ophthalmic Solution 0.02%	255	228
Latanoprost Ophthalmic Solution 0.005%	250	236

Primary outcome: Intraocular Pressure (IOP)

Time frame: 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	PG324 Ophthalmic Solution n = 245	Netarsudil (AR-13324) Ophthalmic Solution 0.02% n = 255	Latanoprost Ophthalmic Solution 0.005% n = 250
Day 1, 0800 hours	24.69 (3.422)	24.66 (3.148)	24.75 (3.240)
Day 1, 1000 hours	23.33 (3.399)	23.40 (3.538)	23.23 (3.339)
Day 1, 1600 hours	22.37 (3.492)	22.76 (3.558)	22.59 (3.451)
Day 15, 0800 hours	16.06 (3.370)	19.35 (4.279)	18.10 (3.375)
Day 15, 1000 hours	15.31 (3.272)	17.99 (3.909)	17.61 (3.264)
Day 15, 1600 hours	15.16 (3.032)	17.53 (3.772)	17.08 (3.283)
Day 43, 0800 hours	16.43 (3.717)	19.52 (4.273)	17.93 (3.586)
Day 43, 1000 hours	15.54 (3.533)	18.40 (3.810)	17.35 (3.224)

PG324 Ophthalmic Solution vs Netarsudil (AR-13324) Ophthalmic Solution 0.02%: p <0.0001, t-test, 2 sided
PG324 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%: p <0.0001, t-test, 2 sided

Population analysed: Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation

Adverse events

Time frame: Adverse event data was collected during the 90 day treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PG324 Ophthalmic Solution	2 of 244 (0.8%)	157 of 244 (64.3%)	0 of 244
Netarsudil (AR-13324) Ophthalmic Solution 0.02%	6 of 255 (2.4%)	143 of 255 (56.1%)	1 of 255
Latanoprost Ophthalmic Solution 0.005%	5 of 251 (2%)	78 of 251 (31.1%)	0 of 251

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationWalter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
Derived from this study: PubMed 32166538Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.
Derived from this study: PubMed 31981106Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.
Individual participant dataSharing planned: No

Related trials for Open-angle Glaucoma

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Recruiting
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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.

Theresa Heah, MD, MBA study director

Aerie Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 18 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 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraocular Pressure (IOP) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674854, which also lists 3 linked publications.

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 May 2019.