Trial Outcomes & Findings for Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG) (NCT NCT00758342)
NCT ID: NCT00758342
Last Updated: 2023-12-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Screening: Week 12; (At 9 am and 4 pm time points)
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% + Brinzolamide 1.0%
|
Travoprost 0.004% + Tears Natural
Travoprost 0.004% + Tears Natural
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Baseline characteristics by cohort
| Measure |
Travoprost 0.004% + Brinzolamide 1.0%
n=19 Participants
Travoprost 0.004% + Brinzolamide 1.0%
|
Travoprost 0.004% + Tears Natural
n=18 Participants
Travoprost 0.004% + Tears Natural
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening: Week 12; (At 9 am and 4 pm time points)Outcome measures
| Measure |
Travoprost 0.004% + Brinzolamide 1.0%
n=19 Participants
Travoprost 0.004% + Brinzolamide 1.0%
|
Travoprost 0.004% + Tears Natural
n=18 Participants
Travoprost 0.004% + Tears Natural
|
|---|---|---|
|
Mean IOP (Intraocular Pressure)
9 AM measurement
|
17.58 mm Hg (millimeters mercury)
Standard Deviation 4.29
|
20.59 mm Hg (millimeters mercury)
Standard Deviation 3.70
|
|
Mean IOP (Intraocular Pressure)
4 PM measurement
|
17.11 mm Hg (millimeters mercury)
Standard Deviation 4.50
|
18.50 mm Hg (millimeters mercury)
Standard Deviation 3.05
|
Adverse Events
Travoprost 0.004% + Brinzolamide 1.0%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Travoprost 0.004% + Tears Natural
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality agreement
- Publication restrictions are in place
Restriction type: OTHER