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Trial record 45 of 152 for:    Brimonidine

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

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ClinicalTrials.gov Identifier: NCT01675609
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Eye Therapies, LLC

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

Condition or disease Intervention/treatment Phase
Ocular Redness Drug: Placebo Drug: Brimonidine tartrate 0.025% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
1 drop in each eye daily for up to 35 days

Experimental: Brimonidine Tartrate 0.025% Drug: Brimonidine tartrate 0.025%
1 drop in each eye for up to 35 days




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675609


Locations
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United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Eye Therapies, LLC

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Responsible Party: Eye Therapies, LLC
ClinicalTrials.gov Identifier: NCT01675609     History of Changes
Other Study ID Numbers: 11-100-0015
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Brimonidine Tartrate
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs