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Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Subjects.

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ClinicalTrials.gov Identifier: NCT01959243
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 safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51% of subjects will be 40 years of age or older.

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 : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% in a Population of Pediatric, Adult, and Geriatric Subjects.
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 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 four weeks.
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 four weeks.
Drug: Vehicle



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Overall visits to Visit 4 (Day 36) ]
    Comparison of adverse events in the treated group vs vehicle group


Secondary Outcome Measures :
  1. Drop Comfort [ Time Frame: Visit 1 (Day 1) ]
    Measured on a scale of 0-10.

  2. Alertness [ Time Frame: Visit 2 (Day 15), Visit 3 (Day 29), and Visit 4 (Day 36) ]
    Alertness measured at 90-180 minutes after administration of the test product using a 6 point alertness scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must be at least 5 years of age at Visit 1 of either sex gender and any race or ethnicity;
  • Have ocular health within normal limits, including a calculated best- corrected (if necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

  • Have any ocular/systemic health problems
  • Use of any disallowed medications during the period indicated prior to Visit 1 and for the duration of the study.

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): NCT01959243


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

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01959243     History of Changes
Other Study ID Numbers: 862
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
Vascular Diseases
Cardiovascular Diseases
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