Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
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ClinicalTrials.gov Identifier: NCT02057575 |
Recruitment Status :
Completed
First Posted : February 7, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Open Angle Glaucoma Ocular Hypertension | Drug: PG324 Ophthalmic Solution 0.01% Drug: PG324 Ophthalmic Solution 0.02% Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02% Drug: Latanoprost Ophthalmic Solution 0.005% | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 298 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: PG324 Ophthalmic Solution 0.01%
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
|
Drug: PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU) |
Experimental: PG324 Ophthalmic Solution 0.02%
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
|
Drug: PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU) |
Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
|
Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU) |
Active Comparator: Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
|
Drug: Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU) |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
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)
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057575

Study Director: | Nancy Ramirez, M.S. | Aerie Pharmaceuticals, Inc. |
Responsible Party: | Aerie Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02057575 |
Other Study ID Numbers: |
PG324-CS201 |
First Posted: | February 7, 2014 Key Record Dates |
Results First Posted: | June 4, 2019 |
Last Update Posted: | June 4, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Open Angle Glaucoma Ocular Hypertension Intraocular Pressure AR13324 PG324 |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases |
Eye Diseases Latanoprost Pharmaceutical Solutions Ophthalmic Solutions Antihypertensive Agents |