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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryIntraocular 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.
SecondaryExtent of Exposure12 monthsExposure to study medication in days for all treatment groups

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIntraocular 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) populationmmHgMEAN
SECONDARYExtent of Exposure12 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.
daysMEAN

Results by group39

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Intraocular Pressure (IOP)PG324 Ophthalmic SolutionDay 1, 0800 hours24.84Standard Deviation 3.316mmHg
Intraocular Pressure (IOP)AR-13324 Ophthalmic Solution 0.02%Day 1, 0800 hours24.81Standard Deviation 3.335mmHg
Intraocular Pressure (IOP)Latanoprost Ophthalmic Solution 0.005%Day 1, 0800 hours24.59Standard Deviation 2.914mmHg
Intraocular Pressure (IOP)PG324 Ophthalmic SolutionDay 1, 1000 hours23.72Standard Deviation 3.587mmHg
Intraocular Pressure (IOP)AR-13324 Ophthalmic Solution 0.02%Day 1, 1000 hours23.45Standard Deviation 3.510mmHg
Intraocular Pressure (IOP)Latanoprost Ophthalmic Solution 0.005%Day 1, 1000 hours23.43Standard Deviation 3.385mmHg
Intraocular Pressure (IOP)PG324 Ophthalmic SolutionDay 1, 1600 hours22.59Standard Deviation 3.610mmHg
Intraocular Pressure (IOP)AR-13324 Ophthalmic Solution 0.02%Day 1, 1600 hours22.63Standard Deviation 3.674mmHg
Intraocular Pressure (IOP)Latanoprost Ophthalmic Solution 0.005%Day 1, 1600 hours23.43Standard Deviation 3.370mmHg
Intraocular Pressure (IOP)PG324 Ophthalmic SolutionDay 15, 0800 hours15.68Standard Deviation 3.532mmHg

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPG324 Ophthalmic Solution 0.02%/0.005%238
Overall StudySTARTEDAR-13324 Ophthalmic Solution 0.02%244
Overall StudySTARTEDLatanoprost Ophthalmic Solution 0.005%236
Overall StudyCOMPLETEDPG324 Ophthalmic Solution 0.02%/0.005%159
Overall StudyCOMPLETEDAR-13324 Ophthalmic Solution 0.02%148
Overall StudyCOMPLETEDLatanoprost Ophthalmic Solution 0.005%203
Overall StudyNOT COMPLETEDPG324 Ophthalmic Solution 0.02%/0.005%79
Overall StudyNOT COMPLETEDAR-13324 Ophthalmic Solution 0.02%96
Overall StudyNOT COMPLETEDLatanoprost Ophthalmic Solution 0.005%33

Adverse events114

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherConjunctival HyperaemiaEye disordersPG324 Ophthalmic Solution133238133
otherConjunctival HyperaemiaEye disordersAR-13324 Ophthalmic Solution 0.02%115243115
otherConjunctival HyperaemiaEye disordersLatanoprost Ophthalmic Solution 0.005%4423744
otherCornea VerticillataEye disordersPG324 Ophthalmic Solution3923839
otherCornea VerticillataEye disordersAR-13324 Ophthalmic Solution 0.02%3224332
otherCornea VerticillataEye disordersLatanoprost Ophthalmic Solution 0.005%02370
otherEye PruritusEye disordersPG324 Ophthalmic Solution2023820
otherEye PruritusEye disordersAR-13324 Ophthalmic Solution 0.02%2024320
otherEye PruritusEye disordersLatanoprost Ophthalmic Solution 0.005%22372
otherLacrimation IncreasedEye disordersPG324 Ophthalmic Solution1523815

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPG324 Ophthalmic Solution0238
Total, all-cause mortalityAR-13324 Ophthalmic Solution 0.02%1243
Total, all-cause mortalityLatanoprost Ophthalmic Solution 0.005%0237
Total, other adverse eventsPG324 Ophthalmic Solution169238
Total, other adverse eventsAR-13324 Ophthalmic Solution 0.02%160243
Total, other adverse eventsLatanoprost Ophthalmic Solution 0.005%74237
Total, serious adverse eventsPG324 Ophthalmic Solution5238
Total, serious adverse eventsAR-13324 Ophthalmic Solution 0.02%10243
Total, serious adverse eventsLatanoprost Ophthalmic Solution 0.005%10237

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
32166538DERIVED

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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