Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure - Full Text View

Purpose

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: PG324 Ophthalmic Solution 0.01% Drug: PG324 Ophthalmic Solution 0.02% Drug: Netarsudil (AR-13324) Ophthalmic Solution Drug: Latanoprost Ophthalmic Solution	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:

Mean diurnal Intraocular Pressure [ Time Frame: Day 29 ]
Mean diurnal intraocular pressure across subjects within treatment group at Day 29

Secondary Outcome Measures:

Mean Intraocular Pressure [ Time Frame: Day 8, Day 15, and Day 29 ]
Mean intraocular pressure across subjects within treatment group at each post-treatment timepoint on Day 8, Day 15, Day 29.
Mean Change in Intraocular Pressure [ Time Frame: Day 8, Day 15, and Day 29 ]
Mean change from diurnally adjusted baseline intraocular pressure at each timepoint on Day 8, Day 15, Day 29.


Enrollment:	298
Study Start Date:	January 2014
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.01%	Drug: PG324 Ophthalmic Solution 0.01% 1 drop daily (evening)
Experimental: PG324 Ophthalmic Solution 0.02% PG324 Ophthalmic Solution 0.02%	Drug: PG324 Ophthalmic Solution 0.02% 1 drop daily (evening)
Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution	Drug: Netarsudil (AR-13324) Ophthalmic Solution 1 drop daily (evening)
Active Comparator: Latanoprost Ophthalmic Solution Latanoprost Ophthalmic Solution	Drug: Latanoprost Ophthalmic Solution 1 drop daily (evening)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or greater.
Diagnosis of open angle glaucoma or ocular hypertension
Corrected visual acuity in each eye equivalent to 20/200
Able and willing to give signed informed consent and follow study instructions.
Additional protocol-specific criteria may apply

Exclusion Criteria:

Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), 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.
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
Additional protocol-specific criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057575

Locations


United States, New Jersey
Aerie Clinical Operations
Bedminster, New Jersey, United States, 07921

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators


Study Director:	Nancy Ramirez, M.S.	Aerie Pharmaceuticals, Inc.

More Information


Responsible Party:	Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02057575 History of Changes
Other Study ID Numbers:	PG324-CS201
Study First Received:	February 6, 2014
Last Updated:	January 21, 2016

Keywords provided by Aerie Pharmaceuticals:


Open Angle Glaucoma Ocular Hypertension Intraocular Pressure AR13324 PG324

Additional relevant MeSH terms:


Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases Cardiovascular Diseases	Eye Diseases Pharmaceutical Solutions Latanoprost Ophthalmic Solutions Antihypertensive Agents

ClinicalTrials.gov processed this record on June 23, 2017