Trial · NCT02558400
Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
NCT02558400, Phase 3, Completed, Aerie Pharmaceuticals; results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT02558400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02558400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT02558400
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 718 participants, actual
- Lead sponsor
- Aerie Pharmaceuticals
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Interventions
- PG324 Ophthalmic Solution 0.02%/0.005%, Netarsudil (AR-13324) Ophthalmic Solution 0.02%, Latanoprost Ophthalmic Solution 0.005%
- First posted
- 2015-09-24
- Last updated
- 2019-06-04
- Results first posted
- 2019-06-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure (IOP) | 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. |
| Secondary | Extent of Exposure | 12 months | Exposure to study medication in days for all treatment groups |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraocular Pressure (IOP) | 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) | Intent to Treat (ITT) population | mmHg | MEAN |
| SECONDARY | Extent of Exposure | 12 months | The safety population= all randomized subjects who received at least 1 dose of study medication. The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population. | days | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure (IOP) | PG324 Ophthalmic Solution | Day 1, 0800 hours | 24.84 | Standard Deviation 3.316 | mmHg |
| Intraocular Pressure (IOP) | AR-13324 Ophthalmic Solution 0.02% | Day 1, 0800 hours | 24.81 | Standard Deviation 3.335 | mmHg |
| Intraocular Pressure (IOP) | Latanoprost Ophthalmic Solution 0.005% | Day 1, 0800 hours | 24.59 | Standard Deviation 2.914 | mmHg |
| Intraocular Pressure (IOP) | PG324 Ophthalmic Solution | Day 1, 1000 hours | 23.72 | Standard Deviation 3.587 | mmHg |
| Intraocular Pressure (IOP) | AR-13324 Ophthalmic Solution 0.02% | Day 1, 1000 hours | 23.45 | Standard Deviation 3.510 | mmHg |
| Intraocular Pressure (IOP) | Latanoprost Ophthalmic Solution 0.005% | Day 1, 1000 hours | 23.43 | Standard Deviation 3.385 | mmHg |
| Intraocular Pressure (IOP) | PG324 Ophthalmic Solution | Day 1, 1600 hours | 22.59 | Standard Deviation 3.610 | mmHg |
| Intraocular Pressure (IOP) | AR-13324 Ophthalmic Solution 0.02% | Day 1, 1600 hours | 22.63 | Standard Deviation 3.674 | mmHg |
| Intraocular Pressure (IOP) | Latanoprost Ophthalmic Solution 0.005% | Day 1, 1600 hours | 23.43 | Standard Deviation 3.370 | mmHg |
| Intraocular Pressure (IOP) | PG324 Ophthalmic Solution | Day 15, 0800 hours | 15.68 | Standard Deviation 3.532 | mmHg |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PG324 Ophthalmic Solution 0.02%/0.005% | 238 | |
| Overall Study | STARTED | AR-13324 Ophthalmic Solution 0.02% | 244 | |
| Overall Study | STARTED | Latanoprost Ophthalmic Solution 0.005% | 236 | |
| Overall Study | COMPLETED | PG324 Ophthalmic Solution 0.02%/0.005% | 159 | |
| Overall Study | COMPLETED | AR-13324 Ophthalmic Solution 0.02% | 148 | |
| Overall Study | COMPLETED | Latanoprost Ophthalmic Solution 0.005% | 203 | |
| Overall Study | NOT COMPLETED | PG324 Ophthalmic Solution 0.02%/0.005% | 79 | |
| Overall Study | NOT COMPLETED | AR-13324 Ophthalmic Solution 0.02% | 96 | |
| Overall Study | NOT COMPLETED | Latanoprost Ophthalmic Solution 0.005% | 33 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival Hyperaemia | Eye disorders | PG324 Ophthalmic Solution | 133 | 238 | 133 |
| other | Conjunctival Hyperaemia | Eye disorders | AR-13324 Ophthalmic Solution 0.02% | 115 | 243 | 115 |
| other | Conjunctival Hyperaemia | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 44 | 237 | 44 |
| other | Cornea Verticillata | Eye disorders | PG324 Ophthalmic Solution | 39 | 238 | 39 |
| other | Cornea Verticillata | Eye disorders | AR-13324 Ophthalmic Solution 0.02% | 32 | 243 | 32 |
| other | Cornea Verticillata | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 0 | 237 | 0 |
| other | Eye Pruritus | Eye disorders | PG324 Ophthalmic Solution | 20 | 238 | 20 |
| other | Eye Pruritus | Eye disorders | AR-13324 Ophthalmic Solution 0.02% | 20 | 243 | 20 |
| other | Eye Pruritus | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 2 | 237 | 2 |
| other | Lacrimation Increased | Eye disorders | PG324 Ophthalmic Solution | 15 | 238 | 15 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PG324 Ophthalmic Solution | 0 | 238 |
| Total, all-cause mortality | AR-13324 Ophthalmic Solution 0.02% | 1 | 243 |
| Total, all-cause mortality | Latanoprost Ophthalmic Solution 0.005% | 0 | 237 |
| Total, other adverse events | PG324 Ophthalmic Solution | 169 | 238 |
| Total, other adverse events | AR-13324 Ophthalmic Solution 0.02% | 160 | 243 |
| Total, other adverse events | Latanoprost Ophthalmic Solution 0.005% | 74 | 237 |
| Total, serious adverse events | PG324 Ophthalmic Solution | 5 | 238 |
| Total, serious adverse events | AR-13324 Ophthalmic Solution 0.02% | 10 | 243 |
| Total, serious adverse events | Latanoprost Ophthalmic Solution 0.005% | 10 | 237 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32166538 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02558400
GET https://conductscience.org/api/trials/v1/NCT02558400/results?page=2