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

Purpose

The purpose of this double-masked, randomized, parallel-group study is to evaluate the ocular hypotensive efficacy of a fixed combination of latanoprost and AR-13324 (PG324) 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: AR-13324 Ophthalmic Solution, 0.02% Drug: Latanoprost Ophthalmic Solution, 0.005%	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

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:

Intraocular Pressure [IOP] [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
The mean diurnal IOP across subjects within treatment group.

Secondary Outcome Measures:

Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
Mean IOP across subjects within treatment group at each post-treatment timepoint.
Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
Mean change from diurnally adjusted baseline IOP at each timepoint.


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%	Drug: PG324 Ophthalmic Solution, 0.01% A fixed dose combination of AR-13324 Ophthalmic Solution, 0.01% and Latanoprost Ophthalmic Solution, 0.005%
Experimental: PG324 Ophthalmic Solution, 0.02%	Drug: PG324 Ophthalmic Solution, 0.02% A fixed dose combination of AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005%
Active Comparator: AR-13324 Ophthalmic Solution, 0.02% AR-13324 Ophthalmic Solution, 0.02%	Drug: AR-13324 Ophthalmic Solution, 0.02%
Active Comparator: Latanoprost Ophthalmic Solution, 0.005% Latanoprost Ophthalmic Solution, 0.005%	Drug: Latanoprost Ophthalmic Solution, 0.005%

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or greater.
Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS 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) (e.g., radial keratotomy, PRK, LASIK, etc.)
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 (e.g., cup-disc ratio > 0.8).
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

No publications provided


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:	June 25, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:


Open Angle Glaucoma Ocular Hypertension Intraocular Pressure AR13324 PG324

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015