Back to resultsStudy Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Primary Purpose
Ocular Redness
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Brimonidine tartrate 0.025%
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Redness
Eligibility Criteria
Inclusion Criteria:
- Be at least 40 years of age
- Must have normal ocular health
- Must have history of redness relief drop use or desire to use
Exclusion Criteria:
- Must not have any ocular/systemic health problems
- Must agree to avoid disallowed medications
Sites / Locations
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Brimonidine Tartrate 0.025%
Arm Description
Outcomes
Primary Outcome Measures
Ocular redness
redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary
Secondary Outcome Measures
Ocular Redness
evaluated prior to study medication instillation and at 5 minutes post instillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01675609
Brief Title
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Official Title
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)
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 evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Redness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Brimonidine Tartrate 0.025%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 drop in each eye daily for up to 35 days
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate 0.025%
Intervention Description
1 drop in each eye for up to 35 days
Primary Outcome Measure Information:
Title
Ocular redness
Description
redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary
Time Frame
at specified timepoints for up to 180 minutes
Secondary Outcome Measure Information:
Title
Ocular Redness
Description
evaluated prior to study medication instillation and at 5 minutes post instillation
Time Frame
up to 5 minutes post study medication instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 40 years of age
Must have normal ocular health
Must have history of redness relief drop use or desire to use
Exclusion Criteria:
Must not have any ocular/systemic health problems
Must agree to avoid disallowed medications
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
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