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Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma and Ocular Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Tartrate 0.025%
Vehicle
Sponsored by
Eye Therapies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma and Ocular Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
  • Be willing and able to provide written informed consent prior to any study procedures being performed.
  • Be willing and able to follow all instructions and attend all study visits.
  • Be willing to discontinue use of disallowed medication
  • Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
  • Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.

Sites / Locations

  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Brimonidine Tartrate 0.025%

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

IOP

Secondary Outcome Measures

Full Information

First Posted
September 5, 2012
Last Updated
December 21, 2012
Sponsor
Eye Therapies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01687426
Brief Title
Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official Title
A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye Therapies, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma and Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brimonidine Tartrate 0.025%
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.025%
Intervention Description
1 drop in each eye daily four times a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
1 drop in each eye daily four times a day for 14 days
Primary Outcome Measure Information:
Title
IOP
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
For up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age at Visit 1 (Screening), of either sex and any race Be willing and able to provide written informed consent prior to any study procedures being performed. Be willing and able to follow all instructions and attend all study visits. Be willing to discontinue use of disallowed medication Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy. Exclusion Criteria: Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications. Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
Facility Information:
Facility Name
Clinical Site
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

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