Trial · NCT00761319
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
NCT00761319, Phase 3, Completed, Alcon Research; results first posted 2012-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health. Trials, record NCT00761319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
- NCT number
- NCT00761319
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 705 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Interventions
- Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®), Latanoprost ophthalmic solution 0.005% (XALATAN®)
- First posted
- 2008-09-29
- Last updated
- 2012-04-26
- Results first posted
- 2012-04-23
- Limitations and caveats
The subjective nature of the OSDI may not be sensitive enough to detect the effects of preservatives on the corneal surface. The measurement and quantification of OSD remains a considerable clinical challenge. (Pflugfelder and Baudoin, 2011)
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Day 0, Day 90 | 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. |
| Secondary | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | Day 90 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Day 0, Day 90 | 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. | Units on a scale | MEAN |
| SECONDARY | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | Day 90 | 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. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Travoprost | -9.1 | Standard Error 1.0 | Units on a scale | |
| Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | Latanoprost | -10.2 | Standard Error 0.9 | Units on a scale | |
| Percentage of Patients With Corneal Fluorescein Staining Score = 0 | Travoprost | 37.6 | Percentage of patients | ||
| Percentage of Patients With Corneal Fluorescein Staining Score = 0 | Latanoprost | 38.7 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Travoprost | 353 | |
| Overall Study | STARTED | Latanoprost | 352 | |
| Overall Study | COMPLETED | Travoprost | 305 | |
| Overall Study | COMPLETED | Latanoprost | 318 | |
| Overall Study | NOT COMPLETED | Travoprost | 48 | |
| Overall Study | NOT COMPLETED | Latanoprost | 34 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiac arrest | Cardiac disorders | Travoprost | 1 | 353 | |
| serious | Cardiac arrest | Cardiac disorders | Latanoprost | 0 | 348 | |
| serious | Myocardial Infarction | Cardiac disorders | Travoprost | 1 | 353 | |
| serious | Myocardial Infarction | Cardiac disorders | Latanoprost | 0 | 348 | |
| serious | Intestinal obstruction | Gastrointestinal disorders | Travoprost | 1 | 353 | |
| serious | Intestinal obstruction | Gastrointestinal disorders | Latanoprost | 0 | 348 | |
| serious | Thrombophlebitis | Vascular disorders | Travoprost | 1 | 353 | |
| serious | Thrombophlebitis | Vascular disorders | Latanoprost | 0 | 348 | |
| serious | Adverse drug reaction | General disorders | Travoprost | 0 | 353 | |
| serious | Adverse drug reaction | General disorders | Latanoprost | 1 | 348 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Travoprost | ||
| Total, all-cause mortality | Latanoprost | ||
| Total, other adverse events | Travoprost | 0 | 353 |
| Total, other adverse events | Latanoprost | 0 | 348 |
| Total, serious adverse events | Travoprost | 4 | 353 |
| Total, serious adverse events | Latanoprost | 6 | 348 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Travoprost vs Latanoprost: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00761319
GET https://conductscience.org/api/trials/v1/NCT00761319/events?page=2