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The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost | Experimental | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
|
| Latanoprost | Active Comparator | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) | Drug | Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) | 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. | Day 0, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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236 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and completed the study (intent-to-treat): 215.
Patients were recruited from 22 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for six months prior to Visit 1 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
| FG001 | Latanoprost | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
| BG001 | Latanoprost | One drop self-administered in the study eye(s) once daily at night for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) | 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. | Intent-to-Treat: All patients who received test article and completed the trial. | Posted | Mean | Standard Error | Seconds | Day 0, Day 84 |
|
Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009.
This reporting group includes all patients who received test article.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Travoprost | One drop self administered in the study eye(s) once daily at night for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood urine present | Investigations | MeDRA 11.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | MeDRA 11.0 |
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)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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|
| Latanoprost ophthalmic solution 0.005% (XALATAN®) | Drug | Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost. |
|
|
| Day 0, Day 84 |
| Protocol Violation |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Latanoprost | One drop self administered in the study eye(s) once daily at night for 12 weeks |
|
|
| Secondary | Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score | 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. | Intent-to-Treat: All patients who received test article and completed the trial. | Posted | Mean | Standard Error | Units on a scale | Day 0, Day 84 |
|
|
|
| 1 |
| 117 |
| 7 |
| 117 |
| EG001 | Latanoprost | One drop self administered in the study eye(s) once daily at night for 12 weeks | 2 | 119 | 3 | 119 |
| Dehydration | Metabolism and nutrition disorders | MeDRA 11.0 |
|
| Coronary Arterial Stent Insertion | Surgical and medical procedures | MeDRA 11.0 |
|
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |