Open-angle GlaucomaPhase 3NCT02558400
Double-masked Study of PG324 Ophthalmic Solution in Patients With 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.
Trial summary
To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational… 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 0.02%/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
- 718 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2015to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
- Corrected visual acuity equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
Who cannot join
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- Unmedicated Intraocular pressure ≥36mmHg
- Use of more than 2 ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
Show all 17Show 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
- Used ocular medication in either eye of any kind within 30 days of screening
- Mean central corneal thickness >620µm at screening
- Any abnormality preventing reliable applanation tonometry of either eye
- Clinically significant abnormalities in lab tests at screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
- Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-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 and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.
- 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 once daily (QD), in the evening (PM) in both eyes (OU)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%Drug
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Latanoprost Ophthalmic Solution 0.005%Drug
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
| 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% |
| 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 variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.
Measured: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
Secondary outcomes (1)
Extent of Exposure
Exposure to study medication in days for all treatment groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start18 Sep 2015
- Primary completion17 May 2017
- Study completion30 Jun 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 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Heah, MD, MBA, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558400
- Sponsor's protocol ID
- PG324-CS301
- Status last verified
- May 2019
- First submitted
- 16 Sep 2015
- 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
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
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 Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-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
- NCT02558400
- Acronym / sponsor ID
- PG324-CS301
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 24 Sep 2015 (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 ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.
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 |
| 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 (5 listed)
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
- Corrected visual acuity equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
Key exclusion criteria (17 listed)
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- Unmedicated Intraocular pressure ≥36mmHg
- Use of more than 2 ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
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 once daily (QD), 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 once daily (QD), in the evening (PM) in both eyes (OU) | Drug | AR-13324 Ophthalmic Solution 0.02% |
| Latanoprost Ophthalmic Solution 0.005%1 drop once daily (QD), in the evening (PM) in both eyes (OU) | Drug | Latanoprost Ophthalmic Solution 0.005% |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.
1 secondary outcome
Extent of Exposure
Time frame: 12 months
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 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.
- 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.
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?
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.
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 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 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 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: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)). 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 NCT02558400, 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.