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OpenTrials
Completed

NCT Number: NCT01675609

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

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

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Key information

Conditions

Ocular Redness

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ora, Inc.

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

1 drop in each eye daily for up to 35 days

Brimonidine Tartrate 0.025%

Drug

1 drop in each eye for up to 35 days

Primary outcomes

  1. Ocular redness

    Time frame: at specified timepoints for up to 180 minutes

    redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary

Secondary outcomes

  1. Ocular Redness

    Time frame: up to 5 minutes post study medication instillation

    evaluated prior to study medication instillation and at 5 minutes post instillation

Sponsors and collaborators

Lead sponsor

Eye Therapies, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
First posted
Aug 30, 2012
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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