Trial Outcomes & Findings for Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health (NCT NCT00761319)
NCT ID: NCT00761319
Last Updated: 2012-04-26
Results Overview
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. A negative number represents a perceived improvement in ocular health.
COMPLETED
PHASE3
705 participants
Day 0, Day 90
2012-04-26
Participant Flow
Patients were recruited from 78 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.
705 patients were enrolled in this study. 701 patients were evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy visit (intent to treat): 652.
Participant milestones
| Measure |
Travoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
352
|
|
Overall Study
COMPLETED
|
305
|
318
|
|
Overall Study
NOT COMPLETED
|
48
|
34
|
Reasons for withdrawal
| Measure |
Travoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
21
|
14
|
|
Overall Study
Adverse Event
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Noncompliance
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Nonspecified
|
2
|
2
|
|
Overall Study
Missing
|
1
|
0
|
Baseline Characteristics
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
Baseline characteristics by cohort
| Measure |
Travoprost
n=318 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
n=334 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.3 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
66.3 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
66.3 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Gender
Female
|
185 participants
n=99 Participants
|
216 participants
n=107 Participants
|
401 participants
n=206 Participants
|
|
Gender
Male
|
132 participants
n=99 Participants
|
118 participants
n=107 Participants
|
250 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 90Population: Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.
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. A negative number represents a perceived improvement in ocular health.
Outcome measures
| Measure |
Travoprost
n=305 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
n=314 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
|---|---|---|
|
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
|
-9.1 Units on a scale
Standard Error 1.0
|
-10.2 Units on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Day 90Population: Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.
The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (\>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.
Outcome measures
| Measure |
Travoprost
n=306 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
n=318 Participants
One drop self-administered in the study eye(s) once daily for 90 days
|
|---|---|---|
|
Percentage of Patients With Corneal Fluorescein Staining Score = 0
|
37.6 Percentage of patients
|
38.7 Percentage of patients
|
Adverse Events
Travoprost
Latanoprost
Serious adverse events
| Measure |
Travoprost
n=353 participants at risk
One drop self-administered in the study eye(s) once daily for 90 days
|
Latanoprost
n=348 participants at risk
One drop self-administered in the study eye(s) once daily for 90 days
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.00%
0/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Cardiac disorders
Myocardial Infarction
|
0.28%
1/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.00%
0/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.00%
0/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Vascular disorders
Thrombophlebitis
|
0.28%
1/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.00%
0/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/353 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
0.29%
1/348 • Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
|
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