Trial Outcomes & Findings for Effects of Travatan Z and Xalatan on Ocular Surface Health (NCT NCT00708422)
NCT ID: NCT00708422
Last Updated: 2012-04-23
Results Overview
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
COMPLETED
PHASE4
231 participants
12 weeks (Day 84)
2012-04-23
Participant Flow
Patients were recruited from 21 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and abnormal TBUT were enrolled.
231 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received the test article and completed the study (intent-to-treat): 226.
Participant milestones
| Measure |
Travoprost
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
|
Overall Study
COMPLETED
|
112
|
114
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Travoprost
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of Travatan Z and Xalatan on Ocular Surface Health
Baseline characteristics by cohort
| Measure |
Travoprost
n=112 Participants
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
n=114 Participants
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
Total
n=226 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
|
34 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (Day 84)Population: Intent-to-treat: All patients who received test article and completed the trial.
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
Outcome measures
| Measure |
Travoprost
n=112 Participants
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
n=113 Participants
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
|---|---|---|
|
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
|
0.8 seconds
Standard Deviation 1.5
|
1.1 seconds
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 12 weeks (Day 84)Population: Intent-to-treat: All patients who received test article and completed the trial.
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Outcome measures
| Measure |
Travoprost
n=112 Participants
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
n=112 Participants
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
|---|---|---|
|
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
|
-0.0 Units on a scale
Standard Deviation 11.4
|
-1.3 Units on a scale
Standard Deviation 16.7
|
Adverse Events
Travoprost
Latanoprost
Serious adverse events
| Measure |
Travoprost
n=116 participants at risk
One drop self administered in the study eye(s) once daily at night for 12 weeks
|
Latanoprost
n=115 participants at risk
One drop self-administered in the study eye(s) once daily at night for 12 weeks
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.86%
1/116 • Adverse events were collected for the duration of the study: 11 July 2008 through 03 August 2009.
Patients were queried about any symptoms they may have experienced that would suggest an AE by asking, "Since your last visit, have you had any health problems?" This reporting group includes all patients who received test article.
|
0.00%
0/115 • Adverse events were collected for the duration of the study: 11 July 2008 through 03 August 2009.
Patients were queried about any symptoms they may have experienced that would suggest an AE by asking, "Since your last visit, have you had any health problems?" This reporting group includes all patients who received test article.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/116 • Adverse events were collected for the duration of the study: 11 July 2008 through 03 August 2009.
Patients were queried about any symptoms they may have experienced that would suggest an AE by asking, "Since your last visit, have you had any health problems?" This reporting group includes all patients who received test article.
|
0.87%
1/115 • Adverse events were collected for the duration of the study: 11 July 2008 through 03 August 2009.
Patients were queried about any symptoms they may have experienced that would suggest an AE by asking, "Since your last visit, have you had any health problems?" This reporting group includes all patients who received test article.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER