Open Angle GlaucomaPhase 2NCT02057575
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
A Phase 2 study testing PG324 Ophthalmic Solution 0.01%, PG324 Ophthalmic Solution 0.02% and Netarsudil (AR-13324) Ophthalmic Solution 0.02% in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 23 sites in United States.
Trial summary
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- PG324 Ophthalmic Solution 0.01%, PG324 Ophthalmic Solution 0.02% and Netarsudil (AR-13324) Ophthalmic Solution 0.02%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 23 sitesUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- Corrected visual acuity in each eye equivalent to 20/200 or better
- Able and willing to give signed informed consent and follow study instructions.
Who cannot join
- Ophthalmic:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- Intraocular pressure >36 mmHg
- Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
- Refractive surgery in study eye(s)
Show all 17Show fewer
- Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
- Evidence of ocular infection and inflammation
- Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
- Central corneal thickness greater then 600 μm
- Any abnormality preventing reliable applanation tonometry of either eye
- Systemic:
- Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
- Clinically significant systemic disease
- Participation in any investigational study within 30 days prior to screening
- Changes in systemic medication
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Kenneth Sall, M.D.
Artesia, California, 90701
Texan Eye
Austin, Texas, 78731
Charlotte Eye Ear Nose & Throat Associates, P.A.
Belmont, North Carolina, 28012
Glaucoma Associates of Texas - Dallas Office
Dallas, Texas, 75231
Cataract & Glaucoma Center
El Paso, Texas, 79902
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Michael E. Tepedino, M.D.
High Point, North Carolina, 27262
United Medical Research Institute
Inglewood, California, 90301
Taustine Eye Center
Louisville, Kentucky, 40217
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Clayton Eye Center
Morrow, Georgia, 30260
Aesthetic Eye Care Institute
Newport Beach, California, 92657
Virginia Eye Consultants
Norfolk, Virginia, 23502
Bacharach practice
Petaluma, California, 94954
Centre For Health Care
Poway, California, 92064
Rochester Ophthalmological Group
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Stacy R. Smith, M.D.
Salt Lake City, Utah, 84117
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, 66204
Comprehensive Eye Care
St Louis, Missouri, 63090
The Eye Institute
Tulsa, Oklahoma, 74104
About this study
Official title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- PG324 Ophthalmic Solution 0.01%, PG324 Ophthalmic Solution 0.02%, Netarsudil (AR-13324) Ophthalmic Solution 0.02%, Latanoprost Ophthalmic Solution 0.005%
- Keywords
- Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, AR13324, PG324
- 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 0.01%Drug
1 drop in the evening (PM), once daily (QD), both eyes (OU)
PG324 Ophthalmic Solution 0.02%Drug
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%Drug
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Latanoprost Ophthalmic Solution 0.005%Drug
1 drop in the evening (PM), once daily (QD), both eyes (OU)
| Study group | Role | What they receive |
|---|---|---|
| PG324 Ophthalmic Solution 0.01% | Experimental | Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution Receives: Drug: PG324 Ophthalmic Solution 0.01% |
| PG324 Ophthalmic Solution 0.02% | Experimental | Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution Receives: Drug: PG324 Ophthalmic Solution 0.02% |
| 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)
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Measured: Study treatment was administered for 28 days, and outcome measures collected on Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Ramirez, M.S., Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057575
- Sponsor's protocol ID
- PG324-CS201
- Status last verified
- May 2019
- First submitted
- 6 Feb 2014
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24.
PubMed 26209587
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT02057575
- Acronym / sponsor ID
- PG324-CS201
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, AR13324, PG324
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Posted 4 Jun 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 the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PG324 Ophthalmic Solution 0.01% | Experimental | Drug: PG324 Ophthalmic Solution 0.01%Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution |
| PG324 Ophthalmic Solution 0.02% | Experimental | Drug: PG324 Ophthalmic Solution 0.02%Netarsudil 0.02%, Latanoprost 0.005% fixed combination 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- Corrected visual acuity in each eye equivalent to 20/200 or better
- Able and willing to give signed informed consent and follow study instructions.
Key exclusion criteria (17 listed)
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- Intraocular pressure >36 mmHg
- Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
- Refractive surgery in study eye(s)
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 0.01%1 drop in the evening (PM), once daily (QD), both eyes (OU) | Drug | PG324 Ophthalmic Solution 0.01% |
| PG324 Ophthalmic Solution 0.02%1 drop in the evening (PM), once daily (QD), both eyes (OU) | Drug | PG324 Ophthalmic Solution 0.02% |
| Netarsudil (AR-13324) Ophthalmic Solution 0.02%1 drop in the evening (PM), once daily (QD), both eyes (OU) | Drug | Netarsudil (AR-13324) Ophthalmic Solution 0.02% |
| Latanoprost Ophthalmic Solution 0.005%1 drop in the evening (PM), once daily (QD), both eyes (OU) | Drug | Latanoprost Ophthalmic Solution 0.005% |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26209587Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24.
- 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.
Nancy Ramirez, M.S. study director
Aerie Pharmaceuticals, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG324 Ophthalmic Solution 0.01%, PG324 Ophthalmic Solution 0.02% and Netarsudil (AR-13324) Ophthalmic Solution 0.02% in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 23 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 4 inclusion and 17 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Jun 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: Study treatment was administered for 28 days, and outcome measures collected on Day 29). 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 NCT02057575, which also lists 1 linked publication.
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 4 Jun 2019.