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

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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

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 9, 2013
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01959230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
  • 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).
  • 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)
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 Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects With Ocular Redness.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperemia
Intervention  ICMJE
  • Drug: Brimonidine Tartrate
  • Drug: Vehicle
Study Arms  ICMJE
  • Experimental: Brimonidine Tartrate
    Brimonidine tartrate ophthalmic solution 0.025%, one drop of drug into each eye, four times daily for up to 30 days.
    Intervention: 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.
    Intervention: Drug: Vehicle
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: October 8, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01959230
Other Study ID Numbers  ICMJE 861
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE
Study Director: Quintus Ngumah, OD, PhD Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date July 2014

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