Trial Outcomes & Findings for Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness (NCT NCT01959230)

NCT ID: NCT01959230

Last Updated: 2019-10-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1

Results posted on

2019-10-23

Participant Flow

Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.

Participant milestones

Participant milestones
Measure	Brimonidine Tartrate Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle 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 Study STARTED	40	20
Overall Study Received at Least 1 Dose of Study Drug	40	20
Overall Study COMPLETED	36	19
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brimonidine Tartrate Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle 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 Study Failure to follow study procedures	0	1
Overall Study Administrative reasons	2	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brimonidine Tartrate n=40 Participants Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle n=20 Participants 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 n=60 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 15.37 • n=5 Participants	47.4 years STANDARD_DEVIATION 15.36 • n=7 Participants	47.5 years STANDARD_DEVIATION 15.24 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate n=40 Participants Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle n=20 Participants Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale Predose	1.82 units on a scale Standard Deviation 0.412	1.71 units on a scale Standard Deviation 0.365
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 5 minutes Postdose	0.58 units on a scale Standard Deviation 0.497	1.40 units on a scale Standard Deviation 0.666
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 15 minutes Postdose	0.58 units on a scale Standard Deviation 0.497	1.35 units on a scale Standard Deviation 0.651
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 30 minutes Postdose	0.59 units on a scale Standard Deviation 0.511	1.40 units on a scale Standard Deviation 0.641
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 60 minutes Postdose	0.61 units on a scale Standard Deviation 0.509	1.40 units on a scale Standard Deviation 0.646
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 90 minutes Postdose	0.60 units on a scale Standard Deviation 0.476	1.45 units on a scale Standard Deviation 0.672
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 120 minutes Postdose	0.63 units on a scale Standard Deviation 0.470	1.53 units on a scale Standard Deviation 0.612
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 180 minutes Postdose	0.73 units on a scale Standard Deviation 0.449	1.54 units on a scale Standard Deviation 0.586
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale 240 minutes Postdose	0.82 units on a scale Standard Deviation 0.474	1.54 units on a scale Standard Deviation 0.575

SECONDARY outcome

Timeframe: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate n=40 Participants Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle n=20 Participants Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Ocular Redness as Measured by the Participant Daily Predose Score of Day 1 to Day 15	1.52 units on a scale Standard Deviation 0.857	1.83 units on a scale Standard Deviation 0.975
Ocular Redness as Measured by the Participant Daily Postdose Score of Day 1 to Day 15	0.85 units on a scale Standard Deviation 0.860	1.85 units on a scale Standard Deviation 0.843
Ocular Redness as Measured by the Participant Daily Predose Score of Day 15 to Day 29	1.45 units on a scale Standard Deviation 0.811	1.59 units on a scale Standard Deviation 1.012
Ocular Redness as Measured by the Participant Daily Postdose Score of Day 15 to Day 29	0.80 units on a scale Standard Deviation 0.810	1.63 units on a scale Standard Deviation 0.887
Ocular Redness as Measured by the Participant Daily Score of Day 29 to Day 36	1.69 units on a scale Standard Deviation 0.885	1.69 units on a scale Standard Deviation 0.897

SECONDARY outcome

Timeframe: 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 measures

Outcome measures
Measure	Brimonidine Tartrate n=40 Participants Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle n=20 Participants Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Predose on Day 1	1.82 units on a scale Standard Deviation 0.412	1.71 units on a scale Standard Deviation 0.365
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 1 min Postdose on Day 1	-1.06 units on a scale Standard Deviation 0.625	-0.23 units on a scale Standard Deviation 0.486
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 360 min Postdose on Day 1	-0.78 units on a scale Standard Deviation 0.517	-0.10 units on a scale Standard Deviation 0.440
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 480 min Postdose on Day 1	-0.63 units on a scale Standard Deviation 0.570	-0.13 units on a scale Standard Deviation 0.459
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Predose on Day 15	1.57 units on a scale Standard Deviation 0.645	1.24 units on a scale Standard Deviation 0.349
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 1 min Postdose on Day 15	-0.78 units on a scale Standard Deviation 0.496	-0.16 units on a scale Standard Deviation 0.279
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 5 min Postdose on Day 15	-1.03 units on a scale Standard Deviation 0.569	-0.25 units on a scale Standard Deviation 0.354
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Predose on Day 29	1.64 units on a scale Standard Deviation 0.461	1.36 units on a scale Standard Deviation 0.304
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 1 min Postdose on Day 29	-0.88 units on a scale Standard Deviation 0.469	-0.24 units on a scale Standard Deviation 0.306
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale Change from Predose at 5 min Postdose on Day 29	-1.21 units on a scale Standard Deviation 0.416	-0.37 units on a scale Standard Deviation 0.347

Adverse Events

Brimonidine Tartrate

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Brimonidine Tartrate Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brimonidine Tartrate n=40 participants at risk Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Brimonidine Tartrate Vehicle n=20 participants at risk Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Infections and infestations Bronchitis	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Eye disorders Foreign body sensation in eyes	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Eye disorders Lacrimation increased	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Gastrointestinal disorders Abdominal discomfort	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Eye disorders Eye pruritus	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
General disorders Pain	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	5.0% 1/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Injury, poisoning and procedural complications Muscle strain	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Infections and infestations Nasopharyngitis	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).
Injury, poisoning and procedural complications Ligament sprain	2.5% 1/40 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/20 • Baseline up to Day 36 All randomized participants who received at least 1 dose of study drug (Safety Population).

Additional Information

Director, Medical Affairs

Bausch & Lomb Incorporated

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER