Clinical trial NCT00523250: Ocular Hypotensive Efficacy of AR-102
Official title: A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

Detailed description: A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater (male, or female not of childbearing potential).
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
* Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better

Exclusion Criteria:

* Known hypersensitivity to any component of the formulation or to topical anesthetics
* Previous glaucoma intraocular surgery or laser procedures in study eye(s)
* Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
* Participation in any study involving an investigational drug within the past 30 days.

Primary outcomes:
measure: The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
timeFrame: One week
Secondary outcomes:
measure: The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires
timeFrame: One week
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Soilsh Practice
state: California
city: Petaluma
country: United States
facility: Bacharach practice
state: California
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Charlotte
country: United States
facility: Mundorf Practice
state: North Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: Thomas Van Haarlem, MD
role: STUDY_DIRECTOR
References: