Trial Outcomes & Findings for Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide (NCT NCT01062971)
NCT ID: NCT01062971
Last Updated: 2019-08-01
Results Overview
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
basal (day 1 ) and final (day 60)
Results posted on
2019-08-01
Participant Flow
Participant milestones
| Measure |
A (Triple Therapy)
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
dorzolamide-timolol group
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
63
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
A (Triple Therapy)
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
dorzolamide-timolol group
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Baseline characteristics by cohort
| Measure |
A (Triple Therapy)
n=56 eyes
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
n=56 eyes
dorzolamide-timolol group
|
Total
n=112 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
european
|
6 subjects
n=5 Participants
|
4 subjects
n=7 Participants
|
10 subjects
n=5 Participants
|
|
Race/Ethnicity, Customized
african
|
0 subjects
n=5 Participants
|
1 subjects
n=7 Participants
|
1 subjects
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
48 subjects
n=5 Participants
|
50 subjects
n=7 Participants
|
98 subjects
n=5 Participants
|
|
Race/Ethnicity, Customized
asian
|
2 subjects
n=5 Participants
|
1 subjects
n=7 Participants
|
3 subjects
n=5 Participants
|
|
Region of Enrollment
Mexico
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: basal (day 1 ) and final (day 60)Population: the analysis of the groups was by protocol
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
Outcome measures
| Measure |
A (Triple Therapy)
n=56 Participants
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
n=56 Participants
dorzolamide-timolol group
|
|---|---|---|
|
Intraocular Pressure (IOP)
baseline
|
24.1 mmHg
Standard Deviation 2.6
|
23.6 mmHg
Standard Deviation 2.2
|
|
Intraocular Pressure (IOP)
Final
|
13.9 mmHg
Standard Deviation 2.9
|
16.9 mmHg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: basal (day 1 ) and security call (day 75)Population: the analysis of the study groups was done by protocol
the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.
Outcome measures
| Measure |
A (Triple Therapy)
n=56 Participants
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
n=56 Participants
dorzolamide-timolol group
|
|---|---|---|
|
Number of Adverse Events
|
2 events
|
6 events
|
Adverse Events
A (Triple Therapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
B (Doble Therapy)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A (Triple Therapy)
n=56 participants at risk
Dorzolamide-Timolol-Brimonidine group
|
B (Doble Therapy)
n=56 participants at risk
dorzolamide-timolol group
|
|---|---|---|
|
Eye disorders
ocular pain
|
1.8%
1/56 • Number of events 1 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
5.4%
3/56 • Number of events 3 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
|
Eye disorders
ocular burning
|
1.8%
1/56 • Number of events 1 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
3.6%
2/56 • Number of events 2 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
|
Eye disorders
chemosis
|
0.00%
0/56 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
1.8%
1/56 • Number of events 1 • the evaluation of the adverse events was made during the 60 days of treatment and in a safety call at 15 days after the end of the clinical stage
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee only the sponsor can publish the results of the authorization, if the IP wishes to report or discuss the results, it must request the sponsor a signed agreement.
- Publication restrictions are in place
Restriction type: OTHER