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The purpose of the 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 for 90 days |
|
| Latanoprost | Active Comparator | One drop self-administered in the study eye(s) once daily for 90 days |
|
| 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 90 days. Referred to as travoprost. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change at Day 90 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. A negative number represents a perceived improvement in ocular health. | Day 0, Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 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. | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost | One drop self-administered in the study eye(s) once daily for 90 days |
| FG001 | Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days |
| 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 for 90 days |
| BG001 | Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days |
| 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 Day 90 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. A negative number represents a perceived improvement in ocular health. | 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. | Posted | Mean | Standard Error | Units on a scale | Day 0, Day 90 |
|
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.
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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 for 90 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) |
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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 90 days. Referred to as latanoprost. |
|
|
| Withdrawal by Subject |
|
| Noncompliance |
|
| Lost to Follow-up |
|
| Nonspecified |
|
| Missing |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | One gender response is missing from the Travatan Z arm. | Number | participants |
|
One drop self-administered in the study eye(s) once daily for 90 days
| OG001 | Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days |
|
|
| Secondary | Percentage of Patients With Corneal Fluorescein Staining Score = 0 | 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. | 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. | Posted | Number | Percentage of patients | Day 90 |
|
|
|
| 4 |
| 353 |
| 0 |
| 353 |
| EG001 | Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days | 6 | 348 | 0 | 348 |
| Myocardial Infarction | Cardiac disorders | MedDRA (11.0) |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) |
|
| Thrombophlebitis | Vascular disorders | MedDRA (11.0) |
|
| Adverse drug reaction | General disorders | MedDRA (11.0) |
|
| Oedema peripheral | General disorders | MedDRA (11.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (11.0) |
|
| Mastectomy | Surgical and medical procedures | MedDRA (11.0) |
|
| Hypotension | Vascular disorders | MedDRA (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 |