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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01959230
Collaborator
ORA, Inc. (Industry)
60
1
2
1.4
42.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brimonidine Tartrate
  • Drug: Vehicle
  • Drug: Sodium Fluorescein
  • Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 7, 2013
Actual Primary Completion Date :
Dec 20, 2013
Actual Study Completion Date :
Dec 20, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Brimonidine Tartrate
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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale [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.

Secondary Outcome Measures

  1. Ocular Redness as Measured by the Participant [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.

  2. Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch & Lomb Incorporated Memphis Tennessee United States 38119

Sponsors and Collaborators

  • Bausch & Lomb Incorporated
  • ORA, Inc.

Investigators

  • Study Director: Heleen DeCory, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01959230
Other Study ID Numbers:
  • 861
First Posted:
Oct 9, 2013
Last Update Posted:
Oct 23, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Bausch & Lomb Incorporated
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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
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

Baseline Characteristics

Arm/Group Title Brimonidine Tartrate Brimonidine Tartrate Vehicle Total
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 Participants 40 20 60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
47.6
(15.37)
47.4
(15.36)
47.5
(15.24)
Sex: Female, Male (Count of Participants)
Female
22
55%
16
80%
38
63.3%
Male
18
45%
4
20%
22
36.7%

Outcome Measures

1. Primary Outcome
Title Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
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

Outcome Measure Data

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
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.
Measure Participants 40 20
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
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

Outcome Measure Data

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
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.
Measure Participants 40 20
Daily Predose Score of Day 1 to Day 15
1.52
(0.857)
1.83
(0.975)
Daily Postdose Score of Day 1 to Day 15
0.85
(0.860)
1.85
(0.843)
Daily Predose Score of Day 15 to Day 29
1.45
(0.811)
1.59
(1.012)
Daily Postdose Score of Day 15 to Day 29
0.80
(0.810)
1.63
(0.887)
Daily Score of Day 29 to Day 36
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
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

Outcome Measure Data

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
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.
Measure Participants 40 20
Predose on Day 1
1.82
(0.412)
1.71
(0.365)
Change from Predose at 1 min Postdose on Day 1
-1.06
(0.625)
-0.23
(0.486)
Change from Predose at 360 min Postdose on Day 1
-0.78
(0.517)
-0.10
(0.440)
Change from Predose at 480 min Postdose on Day 1
-0.63
(0.570)
-0.13
(0.459)
Predose on Day 15
1.57
(0.645)
1.24
(0.349)
Change from Predose at 1 min Postdose on Day 15
-0.78
(0.496)
-0.16
(0.279)
Change from Predose at 5 min Postdose on Day 15
-1.03
(0.569)
-0.25
(0.354)
Predose on Day 29
1.64
(0.461)
1.36
(0.304)
Change from Predose at 1 min Postdose on Day 29
-0.88
(0.469)
-0.24
(0.306)
Change from Predose at 5 min Postdose on Day 29
-1.21
(0.416)
-0.37
(0.347)

Adverse Events

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
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 (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Brimonidine Tartrate Brimonidine Tartrate Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/40 (0%) 0/20 (0%)
Other (Not Including Serious) Adverse Events
Brimonidine Tartrate Brimonidine Tartrate Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 10/40 (25%) 1/20 (5%)
Eye disorders
Foreign body sensation in eyes 1/40 (2.5%) 0/20 (0%)
Lacrimation increased 1/40 (2.5%) 0/20 (0%)
Eye pruritus 1/40 (2.5%) 0/20 (0%)
Gastrointestinal disorders
Abdominal discomfort 1/40 (2.5%) 0/20 (0%)
General disorders
Pain 1/40 (2.5%) 0/20 (0%)
Infections and infestations
Bronchitis 1/40 (2.5%) 0/20 (0%)
Nasopharyngitis 1/40 (2.5%) 0/20 (0%)
Injury, poisoning and procedural complications
Muscle strain 1/40 (2.5%) 0/20 (0%)
Ligament sprain 1/40 (2.5%) 0/20 (0%)
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome 1/40 (2.5%) 0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion 0/40 (0%) 1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact Sponsor directly for additional information.

Results Point of Contact

Name/Title Director, Medical Affairs
Organization Bausch & Lomb Incorporated
Phone
Email Heleen.DeCory@bausch.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01959230
Other Study ID Numbers:
  • 861
First Posted:
Oct 9, 2013
Last Update Posted:
Oct 23, 2019
Last Verified:
Oct 1, 2019