Trial Outcomes & Findings for Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension (NCT NCT00471068)
NCT ID: NCT00471068
Last Updated: 2012-04-11
Results Overview
IOP measured at week 6 minus IOP measured at baseline
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
At week 0 and week 6
Results posted on
2012-04-11
Participant Flow
Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008
After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor's decision.
Participant milestones
| Measure |
Travatan
|
Cosopt
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Travatan
n=21 Participants
|
Cosopt
n=25 Participants
|
Total
n=46 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
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At week 0 and week 6IOP measured at week 6 minus IOP measured at baseline
Outcome measures
| Measure |
Travatan
n=21 Participants
|
Cosopt
n=25 Participants
|
|---|---|---|
|
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
|
-4.57 millimeters mercury (mm Hg)
Standard Deviation 1.62
|
-4.08 millimeters mercury (mm Hg)
Standard Deviation 2.50
|
Adverse Events
Travatan
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cosopt
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Travatan
n=21 participants at risk
|
Cosopt
n=25 participants at risk
|
|---|---|---|
|
Surgical and medical procedures
Inguinal hernia surgery
|
0.00%
0/21 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
4.0%
1/25 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
Other adverse events
| Measure |
Travatan
n=21 participants at risk
|
Cosopt
n=25 participants at risk
|
|---|---|---|
|
Infections and infestations
Flu
|
0.00%
0/21 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
4.0%
1/25 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
|
Eye disorders
Ocular pruritus
|
4.8%
1/21 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
4.0%
1/25 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/21 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
4.0%
1/25 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
|
Eye disorders
Redness eye
|
4.8%
1/21 • Number of events 1 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
0.00%
0/25 • Run-in (2-4 weeks) + treatment period (6 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place