Trial Outcomes & Findings for A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% (NCT NCT01426867)
NCT ID: NCT01426867
Last Updated: 2013-07-08
Results Overview
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Week 1
Results posted on
2013-07-08
Participant Flow
Subjects were recruited from 5 investigational centers in the United States.
Of the 103 enrolled, 2 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (101).
Participant milestones
| Measure |
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brinzolamide
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
34
|
|
Overall Study
COMPLETED
|
33
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Baseline characteristics by cohort
| Measure |
Brinz/Brim
n=33 Participants
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brinzolamide
n=34 Participants
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brimonidine
n=34 Participants
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 64 years
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
23 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
101 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 1Population: Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Outcome measures
| Measure |
Brinz/Brim
n=33 Participants
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brinzolamide
n=34 Participants
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brimonidine
n=34 Participants
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
|---|---|---|---|
|
Mean Ocular Discomfort Score
|
0.8 Units on a scale
Standard Deviation 0.9
|
0.4 Units on a scale
Standard Deviation 0.6
|
0.3 Units on a scale
Standard Deviation 0.5
|
Adverse Events
Brinz/Brim
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brinzolamide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Brimonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brinz/Brim
n=33 participants at risk
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brinzolamide
n=34 participants at risk
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
Brimonidine
n=34 participants at risk
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
6.1%
2/33 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
11.8%
4/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye irritation
|
6.1%
2/33 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
8.8%
3/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
2/33 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
2.9%
1/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/34 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
|
Additional Information
Matt Walker, PhD, Clinical Project Lead
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER