Trial Outcomes & Findings for Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants (NCT NCT01959243)

Results Overview

TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

507 participants

Primary outcome timeframe

Baseline up to Day 29

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	337	170
Overall Study Received at Least 1 Dose of Study Drug	337	170
Overall Study COMPLETED	324	166
Overall Study NOT COMPLETED	13	4

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 Investigator Decision	3	0
Overall Study Adverse Event	5	2
Overall Study Administrative reasons	2	1
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brimonidine Tartrate n=337 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=170 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=507 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 17.13 • n=5 Participants	41.0 years STANDARD_DEVIATION 17.68 • n=7 Participants	40.8 years STANDARD_DEVIATION 17.30 • n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	100 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	70 Participants n=7 Participants	207 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 29

Population: All randomized participants who received at least 1 dose of study drug (Safety Population).

TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate n=337 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=170 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with at Least 1 TEAE	66 Participants	38 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with at Least 1 Ocular TEAE	44 Participants	25 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with at least 1 Non-Ocular TEAE	23 Participants	16 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with at least 1 Serious TEAE	2 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants Discontinued from Study due to TEAEs	5 Participants	2 Participants

SECONDARY outcome

Timeframe: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1

Population: All randomized participants who received at least 1 dose of study drug (Safety Population).

Drop comfort assessment (0-10 unit scale in which a score of 0 denotes "very comfortable" and 10 is "very uncomfortable") was performed by the participant. Participant's average score across eyes at each time point were used for analysis.

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate n=337 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=170 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.
Drop Comfort Assessment as Assessed by the Participant Upon Dose Installation	0.4 units on a scale Standard Deviation 0.90	0.4 units on a scale Standard Deviation 0.77
Drop Comfort Assessment as Assessed by the Participant 30 Seconds Postdose Installation	0.4 units on a scale Standard Deviation 0.90	0.3 units on a scale Standard Deviation 0.85
Drop Comfort Assessment as Assessed by the Participant 1 Minute Postdose Installation	0.4 units on a scale Standard Deviation 0.83	0.4 units on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29

Population: All randomized participants who received at least 1 dose of study drug (Safety Population) with evaluable alertness data.

An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate n=337 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=170 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.
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 Predose Installation on Day 1	337 Participants	170 Participants
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 Postdose Installation on Day 1	336 Participants	169 Participants
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 Postdose Installation on Day 8	326 Participants	167 Participants
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 Postdose Installation on Day 15	326 Participants	166 Participants
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 Postdose Installation on Day 29	323 Participants	164 Participants

Adverse Events

Brimonidine Tartrate

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Brimonidine Tartrate Vehicle

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brimonidine Tartrate n=337 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=170 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 Gastroenteritis	0.30% 1/337 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/170 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).
Infections and infestations Staphylococcal infection	0.30% 1/337 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/170 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).
Infections and infestations Sinusitis	0.30% 1/337 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).	0.00% 0/170 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).

Other adverse events

Other adverse events
Measure	Brimonidine Tartrate n=337 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=170 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.
Eye disorders Visual Acuity Reduced	4.7% 16/337 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).	5.3% 9/170 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).
Eye disorders Conjunctival Hyperaemia	3.3% 11/337 • Baseline up to Day 29 All randomized participants who received at least 1 dose of study drug (Safety Population).	3.5% 6/170 • Baseline up to Day 29 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