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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects With Ocular Redness.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959230
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for treating ocular redness in a population of adult and geriatric participants with ocular redness.

Condition or disease Intervention/treatment Phase
Hyperemia Drug: Brimonidine Tartrate Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brimonidine Tartrate
Brimonidine tartrate ophthalmic solution 0.025%, one drop of drug into each eye, four times daily for up to 30 days.
Drug: Brimonidine Tartrate
Placebo Comparator: Vehicle
Vehicle of brimonidine tartrate ophthalmic solution, one drop of vehicle into each eye, four times daily for up to 30 days.
Drug: Vehicle



Primary Outcome Measures :
  1. Ocular Redness - Investigator [ Time Frame: 240 minutes ]
    Ocular redness evaluated by the investigator prior to investigational drug instillation and up to 240 minutes post investigational drug instillation (0-4 unit scale, allowing half unit increments) at Visit 1.


Secondary Outcome Measures :
  1. Ocular Redness - Participant [ Time Frame: 5 Weeks ]
    Ocular redness evaluated by the participant as captured in participants' diaries (0-4 unit scale, NOT allowing half unit increments).

  2. Ocular Redness - Investigator [ Time Frame: Visit 1 (Day 1) and Visit 2 (Day 15) and Visit 3 (Day 29) ]
    Ocular redness evaluated by the investigator prior to investigational drug instillation and at up to 480 minutes post investigational drug instillation at Visit 1; 5 minutes post investigational drug instillation at Visits 2 and 3.(0-4 unit scale, allowing half unit increments)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Have a history of redness relief drops use, or expressed a desire to use drops for redness relief, within the last 6 months.
  • Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logMAR or better in each eye, as measured using an ETDRS chart.

Exclusion Criteria:

  • Any ocular/systemic health problems.
  • Use of any 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): NCT01959230


Locations
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United States, New Jersey
Bausch & Lomb Incorporated
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Bausch & Lomb Incorporated
ORA, Inc.
Investigators
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Study Director: Quintus Ngumah, OD, PhD Bausch & Lomb Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01959230     History of Changes
Other Study ID Numbers: 861
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by Bausch & Lomb Incorporated:
Ocular redness
Additional relevant MeSH terms:
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Brimonidine Tartrate
Hyperemia
Erythema
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
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