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

Primary Purpose

Hyperemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Tartrate
Vehicle
Sodium Fluorescein
Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemia focused on measuring Ocular redness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brimonidine Tartrate

Brimonidine Tartrate Vehicle

Arm Description

Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.

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.

Outcomes

Primary Outcome Measures

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

Ocular Redness as Measured by the Participant
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
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.

Full Information

First Posted
October 8, 2013
Last Updated
October 22, 2019
Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01959230
Brief Title
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2013 (Actual)
Primary Completion Date
December 20, 2013 (Actual)
Study Completion Date
December 20, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemia
Keywords
Ocular redness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brimonidine Tartrate
Arm Type
Experimental
Arm Description
Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Arm Title
Brimonidine Tartrate Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate
Intervention Description
Ophthalmic solution to be applied as directed.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Ophthalmic solution to be applied as directed.
Intervention Type
Drug
Intervention Name(s)
Sodium Fluorescein
Intervention Description
For use as needed during the study for evaluating corneal damage.
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention Description
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heleen DeCory
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29461408
Citation
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.
Results Reference
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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

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