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Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

NCT ID: NCT01675609

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Ocular Redness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 drop in each eye daily for up to 35 days

Brimonidine Tartrate 0.025%

Group Type EXPERIMENTAL

Brimonidine tartrate 0.025%

Intervention Type DRUG

1 drop in each eye for up to 35 days

Interventions

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Placebo

1 drop in each eye daily for up to 35 days

Intervention Type DRUG

Brimonidine tartrate 0.025%

1 drop in each eye for up to 35 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eye Therapies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ora, Inc.

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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11-100-0015

Identifier Type: -

Identifier Source: org_study_id