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

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

Tracking Information
First Submitted Date  ICMJE August 28, 2012
First Posted Date  ICMJE August 30, 2012
Last Update Posted Date July 31, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01675609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
Ocular Redness [ Time Frame: up to 5 minutes post study medication instillation ]
evaluated prior to study medication instillation and at 5 minutes post instillation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ocular Redness
Intervention  ICMJE
  • Drug: Placebo
    1 drop in each eye daily for up to 35 days
  • Drug: Brimonidine tartrate 0.025%
    1 drop in each eye for up to 35 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Brimonidine Tartrate 0.025%
    Intervention: Drug: Brimonidine tartrate 0.025%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2013)
57
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2012)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01675609
Other Study ID Numbers  ICMJE 11-100-0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eye Therapies, LLC
Study Sponsor  ICMJE Eye Therapies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eye Therapies, LLC
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP