Trial Outcomes & Findings for Travoprost Five Day Posology Study (NCT NCT01114893)
NCT ID: NCT01114893
Last Updated: 2011-06-23
Results Overview
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
5 days
Results posted on
2011-06-23
Participant Flow
Participant milestones
| Measure |
TRAVATAN
TRAVATAN 0.004% once daily
|
Travoprost Vehicle
Travoprost Vehicle
|
Travoprost Group A
Travoprost Group A
|
Travoprost Group B
Travoprost Group B
|
Travoprost Group C
Travoprost Group C
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
13
|
12
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Travoprost Five Day Posology Study
Baseline characteristics by cohort
| Measure |
TRAVATAN
n=14 Participants
TRAVATAN 0.004% once daily
|
Travoprost Vehicle
n=14 Participants
Travoprost Vehicle
|
Travoprost Group A
n=14 Participants
Travoprost Group A
|
Travoprost Group B
n=13 Participants
Travoprost Group B
|
Travoprost Group C
n=12 Participants
Travoprost Group C
|
Total
n=67 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 5 daysOutcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Outcome measures
| Measure |
Travatan 0.004% QD
n=14 Participants
|
Travoprost Vehicle
n=14 Participants
|
Travoprost Group A
n=14 Participants
|
Travoprost Group B
n=13 Participants
|
Travoprost Group C
n=12 Participants
|
|---|---|---|---|---|---|
|
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
|
-9.8 mm Hg
Interval -12.5 to -7.0
|
-2.9 mm Hg
Interval -4.7 to -1.0
|
-5.0 mm Hg
Interval -6.7 to -3.3
|
-6.5 mm Hg
Interval -8.7 to -4.4
|
-6.8 mm Hg
Interval -8.5 to -5.0
|
SECONDARY outcome
Timeframe: 5 DaysOutcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Outcome measures
| Measure |
Travatan 0.004% QD
n=14 Participants
|
Travoprost Vehicle
n=14 Participants
|
Travoprost Group A
n=14 Participants
|
Travoprost Group B
n=13 Participants
|
Travoprost Group C
n=12 Participants
|
|---|---|---|---|---|---|
|
IOP Change From Baseline at 8 PM on Day 5
|
-3.9 mm Hg
Interval -6.2 to -1.5
|
-0.9 mm Hg
Interval -2.6 to 0.7
|
-2.7 mm Hg
Interval -4.3 to -1.2
|
-5.7 mm Hg
Interval -7.5 to -3.9
|
-4.8 mm Hg
Interval -6.1 to -3.6
|
Adverse Events
TRAVATAN
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Travoprost Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Travoprost Group A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Travoprost Group B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Travoprost Group C
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 |
TRAVATAN
n=14 participants at risk
TRAVATAN 0.004% once daily
|
Travoprost Vehicle
n=14 participants at risk
Travoprost Vehicle
|
Travoprost Group A
n=14 participants at risk
Travoprost Group A
|
Travoprost Group B
n=13 participants at risk
Travoprost Group B
|
Travoprost Group C
n=12 participants at risk
Travoprost Group C
|
|---|---|---|---|---|---|
|
Eye disorders
Eye Pruritus
|
14.3%
2/14 • Number of events 2 • 1 month
|
7.1%
1/14 • Number of events 1 • 1 month
|
7.1%
1/14 • Number of events 1 • 1 month
|
15.4%
2/13 • Number of events 2 • 1 month
|
0.00%
0/12 • 1 month
|
|
Eye disorders
Ocular Hyperaemia
|
28.6%
4/14 • Number of events 4 • 1 month
|
0.00%
0/14 • 1 month
|
35.7%
5/14 • Number of events 5 • 1 month
|
38.5%
5/13 • Number of events 5 • 1 month
|
41.7%
5/12 • Number of events 5 • 1 month
|
|
Eye disorders
Dry Eye
|
7.1%
1/14 • Number of events 1 • 1 month
|
0.00%
0/14 • 1 month
|
7.1%
1/14 • Number of events 1 • 1 month
|
7.7%
1/13 • Number of events 1 • 1 month
|
0.00%
0/12 • 1 month
|
|
Eye disorders
Photophobia
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
23.1%
3/13 • Number of events 3 • 1 month
|
0.00%
0/12 • 1 month
|
|
Eye disorders
Eye Irritation
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
7.7%
1/13 • Number of events 1 • 1 month
|
0.00%
0/12 • 1 month
|
|
Eye disorders
Vision Blurred
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/13 • 1 month
|
8.3%
1/12 • Number of events 1 • 1 month
|
|
Eye disorders
Foreign Body Sensation
|
7.1%
1/14 • Number of events 1 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/13 • 1 month
|
0.00%
0/12 • 1 month
|
|
Eye disorders
Corneal Staining
|
7.1%
1/14 • Number of events 1 • 1 month
|
7.1%
1/14 • Number of events 1 • 1 month
|
7.1%
1/14 • Number of events 1 • 1 month
|
0.00%
0/13 • 1 month
|
8.3%
1/12 • Number of events 1 • 1 month
|
|
Eye disorders
Headache
|
7.1%
1/14 • Number of events 1 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/14 • 1 month
|
0.00%
0/13 • 1 month
|
0.00%
0/12 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place