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Ocular Hypotensive Efficacy of AR-102

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AR-102 0.003% Ophthalmic Solution
AR-102 0.005% Ophthalmic Solution
AR-102 0.01% Ophthalmic Solution
AR-102 0.03% Ophthalmic Solution
AR-102 Vehicle Ophthalmic Solution
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soilsh Practice
  • Bacharach practice
  • Hernando Eye Institute
  • Taustine Eye Center
  • Mundorf Practice
  • Black Hills Regional Eye Institute
  • Texan Eye
  • Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

AR-102 0.003% Ophthalmic Solution

AR-102 0.005% Ophthalmic Solution

AR-102 0.01% Ophthalmic Solution

AR-102 0.03% Ophthalmic Solution

AR-102 Vehicle Ophthalmic Solution

Arm Description

q.d. ocular

q.d. ocular

q.d. ocular

q.d. ocular

q.d. ocular

Outcomes

Primary Outcome Measures

The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2007
Last Updated
April 18, 2014
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00523250
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR-102 0.003% Ophthalmic Solution
Arm Type
Experimental
Arm Description
q.d. ocular
Arm Title
AR-102 0.005% Ophthalmic Solution
Arm Type
Experimental
Arm Description
q.d. ocular
Arm Title
AR-102 0.01% Ophthalmic Solution
Arm Type
Experimental
Arm Description
q.d. ocular
Arm Title
AR-102 0.03% Ophthalmic Solution
Arm Type
Experimental
Arm Description
q.d. ocular
Arm Title
AR-102 Vehicle Ophthalmic Solution
Arm Type
Experimental
Arm Description
q.d. ocular
Intervention Type
Drug
Intervention Name(s)
AR-102 0.003% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
AR-102 0.005% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
AR-102 0.01% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
AR-102 0.03% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
AR-102 Vehicle Ophthalmic Solution
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
Time Frame
One week
Secondary Outcome Measure Information:
Title
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
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Haarlem, MD
Organizational Affiliation
Aerie Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Soilsh Practice
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Bacharach practice
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Mundorf Practice
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

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Ocular Hypotensive Efficacy of AR-102

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