Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 point 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 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health. | Baseline, 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 the total number of patients analyzed. | Day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
726 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy study visit (intent-to-treat): 678.
Patients were recruited from 70 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.
Not provided
| 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 latanprost. |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 point 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 90-day 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 had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population. | Posted | Mean | Standard Error | Units on a scale | Baseline, Day 90 |
|
|
| ||||||||||||||||||||||||||||
| 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 the 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. An Observed Case analysis (OC) was performed for the ITT population. | Posted | Number | percentage of patients | Day 90 |
|
|
Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009.
This reporting group includes all patients who received the test article.
Not provided
| 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 | 5 | 363 | 0 | 363 | ||
| EG001 | Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days | 7 | 363 | 0 | 363 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (11.0) |
| ||
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Convulsion | Nervous system disorders | MedDRA (11.0) |
| ||
| Atrial Fibrillation | Cardiac disorders | MedDRA (11.0) |
| ||
| Brachycardia | Cardiac disorders | MedDRA (11.0) |
| ||
| Coronary Artery Disease | Cardiac disorders | MedDRA (11.0) |
| ||
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Chest Pain | General disorders | MedDRA (11.0) |
| ||
| Diverticulitis | Infections and infestations | MedDRA (11.0) |
| ||
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (11.0) |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) |
|
Not provided
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)
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
|