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

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ClinicalTrials.gov Identifier: NCT01959230
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
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
Results First Submitted Date  ICMJE September 27, 2019
Results First Posted Date  ICMJE October 23, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE November 7, 2013
Actual Primary Completion Date December 20, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale [ Time Frame: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1 ]
Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
Original 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.
Change History Complete list of historical versions of study NCT01959230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • Ocular Redness as Measured by the Participant [ Time Frame: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36 ]
    Ocular redness was scored daily pre-dose and post-dose on Days 1 to 29 and scored daily on Days 30 to 36 by the participant using a 0 to 4 unit scale (not allowing half unit increments). A lower score was indicative of less redness. The LOCF method used for this Secondary Outcome Measure was for imputing missing daily post-dose mean scores for entire days. If ≥1 score was provided for a day, imputation was not done. Imputation was done within the dosing period and separately within the follow-up period. The average (mean) daily pre-dose and post-dose scores for the dosing period Day 1 to Day 15 and dosing period Day 15 to Day 29, and the average (mean) daily score for the follow-up period Day 29 to Day 36 are reported.
  • Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale [ Time Frame: 0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 15 and 29 ]
    Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
Original 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)
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 Participants With Ocular Redness
Official Title  ICMJE A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the 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 the treatment of 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
    Ophthalmic solution to be applied as directed.
  • Drug: Vehicle
    Ophthalmic solution to be applied as directed.
  • Drug: Sodium Fluorescein
    For use as needed during the study for evaluating corneal damage.
  • Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
    For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Study Arms  ICMJE
  • Experimental: Brimonidine Tartrate
    Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
    Interventions:
    • Drug: Brimonidine Tartrate
    • Drug: Sodium Fluorescein
    • Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
  • Placebo Comparator: Brimonidine Tartrate Vehicle
    Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
    Interventions:
    • Drug: Vehicle
    • Drug: Sodium Fluorescein
    • Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Publications * McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018 Mar;95(3):264-271. doi: 10.1097/OPX.0000000000001182.

*   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 December 20, 2013
Actual Primary Completion Date December 20, 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 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (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: Heleen DeCory Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date October 2019

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