Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
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 |
---|---|---|
|
Phase 3 |
Study Design
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
- 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
- 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.
- 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
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.- 861
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
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)
|
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)
|
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
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 | |
Heleen.DeCory@bausch.com |
- 861