Trial Outcomes & Findings for Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma (NCT NCT01711177)
NCT ID: NCT01711177
Last Updated: 2016-07-28
Results Overview
For each subject, all the measurements will be done during an 1 hour appointment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
1 hour
Results posted on
2016-07-28
Participant Flow
Participant milestones
| Measure |
Normal Control
Normal patient placebo
placebo: Placebo
|
Glaucoma Suspect
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo
|
Newly Diagnosed Glaucoma
Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
3
|
3
|
|
Overall Study
COMPLETED
|
10
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Baseline characteristics by cohort
| Measure |
Normal Control
n=10 Participants
Normal patient placebo
placebo: Placebo
|
Glaucoma Suspect
n=3 Participants
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo
|
Newly Diagnosed Glaucoma
n=3 Participants
Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
|
Total
n=16 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 5 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8 • n=7 Participants
|
60 years
STANDARD_DEVIATION 9 • n=5 Participants
|
55 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hourFor each subject, all the measurements will be done during an 1 hour appointment.
Outcome measures
| Measure |
Normal Control
n=10 Participants
Normal patient placebo
placebo: Placebo
|
Glaucoma Suspect
n=3 Participants
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo
|
Newly Diagnosed Glaucoma
n=3 Participants
Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
|
|---|---|---|---|
|
Blood Oxygenation
|
60 percentage of oxygenation
Interval 55.0 to 63.0
|
60 percentage of oxygenation
Interval 55.0 to 63.0
|
60 percentage of oxygenation
Interval 55.0 to 63.0
|
Adverse Events
Normal Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Suspect
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Newly Diagnosed Glaucoma
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
- Publication restrictions are in place