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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants 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
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hyperemia
Interventions Drug: Brimonidine Tartrate
Drug: Vehicle
Drug: Sodium Fluorescein
Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Enrollment 60
Recruitment Details  
Pre-assignment Details Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle
Hide Arm/Group Description Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Period Title: Overall Study
Started 40 20
Received at Least 1 Dose of Study Drug 40 20
Completed 36 19
Not Completed 4 1
Reason Not Completed
Failure to follow study procedures             0             1
Administrative reasons             2             0
Withdrawal by Subject             2             0
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle Total
Hide Arm/Group Description Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. Total of all reporting groups
Overall Number of Baseline Participants 40 20 60
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug (Safety Population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 20 participants 60 participants
47.6  (15.37) 47.4  (15.36) 47.5  (15.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
Female
22
  55.0%
16
  80.0%
38
  63.3%
Male
18
  45.0%
4
  20.0%
22
  36.7%
1.Primary Outcome
Title Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
Hide Description 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.
Time Frame 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (Intent-to-Treat [ITT] Population). Last Observation Carried Forward (LOCF) was used to impute missing data.
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle
Hide Arm/Group Description:
Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Overall Number of Participants Analyzed 40 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Predose 1.82  (0.412) 1.71  (0.365)
5 minutes Postdose 0.58  (0.497) 1.40  (0.666)
15 minutes Postdose 0.58  (0.497) 1.35  (0.651)
30 minutes Postdose 0.59  (0.511) 1.40  (0.641)
60 minutes Postdose 0.61  (0.509) 1.40  (0.646)
90 minutes Postdose 0.60  (0.476) 1.45  (0.672)
120 minutes Postdose 0.63  (0.470) 1.53  (0.612)
180 minutes Postdose 0.73  (0.449) 1.54  (0.586)
240 minutes Postdose 0.82  (0.474) 1.54  (0.575)
2.Secondary Outcome
Title Ocular Redness as Measured by the Participant
Hide Description 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.
Time Frame Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable participant-recorded ocular redness data. LOCF method used as described in the Outcome Measure Description.
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle
Hide Arm/Group Description:
Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Overall Number of Participants Analyzed 40 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Daily Predose Score of Day 1 to Day 15 Number Analyzed 39 participants 20 participants
1.52  (0.857) 1.83  (0.975)
Daily Postdose Score of Day 1 to Day 15 Number Analyzed 39 participants 20 participants
0.85  (0.860) 1.85  (0.843)
Daily Predose Score of Day 15 to Day 29 Number Analyzed 38 participants 19 participants
1.45  (0.811) 1.59  (1.012)
Daily Postdose Score of Day 15 to Day 29 Number Analyzed 39 participants 19 participants
0.80  (0.810) 1.63  (0.887)
Daily Score of Day 29 to Day 36 Number Analyzed 36 participants 19 participants
1.69  (0.885) 1.69  (0.897)
3.Secondary Outcome
Title Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable Investigator-recorded ocular redness data.
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle
Hide Arm/Group Description:
Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Overall Number of Participants Analyzed 40 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Predose on Day 1 Number Analyzed 40 participants 20 participants
1.82  (0.412) 1.71  (0.365)
Change from Predose at 1 min Postdose on Day 1 Number Analyzed 40 participants 20 participants
-1.06  (0.625) -0.23  (0.486)
Change from Predose at 360 min Postdose on Day 1 Number Analyzed 39 participants 20 participants
-0.78  (0.517) -0.10  (0.440)
Change from Predose at 480 min Postdose on Day 1 Number Analyzed 39 participants 19 participants
-0.63  (0.570) -0.13  (0.459)
Predose on Day 15 Number Analyzed 37 participants 20 participants
1.57  (0.645) 1.24  (0.349)
Change from Predose at 1 min Postdose on Day 15 Number Analyzed 37 participants 19 participants
-0.78  (0.496) -0.16  (0.279)
Change from Predose at 5 min Postdose on Day 15 Number Analyzed 37 participants 19 participants
-1.03  (0.569) -0.25  (0.354)
Predose on Day 29 Number Analyzed 36 participants 19 participants
1.64  (0.461) 1.36  (0.304)
Change from Predose at 1 min Postdose on Day 29 Number Analyzed 36 participants 19 participants
-0.88  (0.469) -0.24  (0.306)
Change from Predose at 5 min Postdose on Day 29 Number Analyzed 36 participants 19 participants
-1.21  (0.416) -0.37  (0.347)
Time Frame Baseline up to Day 36
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug (Safety Population).
 
Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle
Hide Arm/Group Description Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
All-Cause Mortality
Brimonidine Tartrate Brimonidine Tartrate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Brimonidine Tartrate Brimonidine Tartrate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brimonidine Tartrate Brimonidine Tartrate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   10/40 (25.00%)   1/20 (5.00%) 
Eye disorders     
Foreign body sensation in eyes  1  1/40 (2.50%)  0/20 (0.00%) 
Lacrimation increased  1  1/40 (2.50%)  0/20 (0.00%) 
Eye pruritus  1  1/40 (2.50%)  0/20 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/40 (2.50%)  0/20 (0.00%) 
General disorders     
Pain  1  1/40 (2.50%)  0/20 (0.00%) 
Infections and infestations     
Bronchitis  1  1/40 (2.50%)  0/20 (0.00%) 
Nasopharyngitis  1  1/40 (2.50%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Muscle strain  1  1/40 (2.50%)  0/20 (0.00%) 
Ligament sprain  1  1/40 (2.50%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Temporomandibular joint syndrome  1  1/40 (2.50%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  0/40 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Please contact Sponsor directly for additional information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Medical Affairs
Organization: Bausch & Lomb Incorporated
EMail: Heleen.DeCory@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01959230    
Other Study ID Numbers: 861
First Submitted: October 8, 2013
First Posted: October 9, 2013
Results First Submitted: September 27, 2019
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019