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Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travatan | Experimental | Travoprost (0.004%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travatan | Drug | Travoprost (0.004%) 1 drop each eye once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure | Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer. | At 5 years. |
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Adult patients of any race and either sex with chronic angle-closure glaucoma.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Europe | Fort Worth | Texas | United States |
Not provided
Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travatan | Travoprost (0.004%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Travatan | Travoprost (0.004%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 Intraocular Pressure | Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer. | Posted | Mean | Standard Deviation | millimeters mercury (mm Hg) | At 5 years. |
|
|
Baseline to 5 years.
Adverse events were both volunteered and solicited.
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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 | Travatan | Travoprost (0.004%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic aneurysm rupture | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 99 |
| 502 |
| 304 |
| 502 |
| Cardiac failure | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Pleural disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Choroidal Neovascularisation | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cluster headache | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hypopharyngeal cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Lung operation | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Lymphadenectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Trabeculoplasty | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Urinary bladder polyp | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Iris hyperpigmentation | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Ocular hyperemia | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 11.0 | Systematic Assessment |
|
Not provided
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |