Trial Outcomes & Findings for A Long-term Safety Study of Once-daily Travatan (NCT NCT00051168)
NCT ID: NCT00051168
Last Updated: 2011-10-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
502 participants
Primary outcome timeframe
At 5 years.
Results posted on
2011-10-07
Participant Flow
Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.
Participant milestones
| Measure |
Travatan
Travoprost (0.004%)
|
|---|---|
|
Overall Study
STARTED
|
502
|
|
Overall Study
COMPLETED
|
367
|
|
Overall Study
NOT COMPLETED
|
135
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long-term Safety Study of Once-daily Travatan
Baseline characteristics by cohort
| Measure |
Travatan
n=502 Participants
Travoprost (0.004%)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
237 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
265 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 5 years.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.
Outcome measures
| Measure |
Travatan
n=502 Participants
Travoprost (0.004%)
|
|---|---|
|
Mean Intraocular Pressure
|
16.5 millimeters mercury (mm Hg)
Standard Deviation 2.6
|
Adverse Events
Travatan
Serious events: 99 serious events
Other events: 304 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Travatan
n=502 participants at risk
Travoprost (0.004%)
|
|---|---|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
3/502 • Number of events 3 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Pneumonia
|
0.80%
4/502 • Number of events 5 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Respiratory tract infection
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Abscess
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.60%
3/502 • Number of events 3 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Reproductive system and breast disorders
Breast mass
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Cataract operation
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
3/502 • Number of events 5 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.60%
3/502 • Number of events 3 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Cholecystitis infective
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Eye disorders
Choroidal Neovascularisation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Cluster headache
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
2/502 • Number of events 4 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Psychiatric disorders
Depression
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Diverticulitis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.20%
1/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Gastrointestinal infection
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Headache
|
0.20%
1/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Hip surgery
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Vascular disorders
Hypertension
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer stage III
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Vascular disorders
Hypotension
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Hysterectomy
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Infection
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Influenza
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Injury, poisoning and procedural complications
Injury
|
1.6%
8/502 • Number of events 8 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Knee operation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Lung operation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.40%
2/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
4/502 • Number of events 4 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Post procedural infection
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.60%
3/502 • Number of events 3 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Renal failure acute
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Spinal operation
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Syncope
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Surgical and medical procedures
Trabeculoplasty
|
0.20%
1/502 • Number of events 2 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Vascular disorders
Varicose vein
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Nervous system disorders
Visual field defect
|
0.20%
1/502 • Number of events 1 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
Other adverse events
| Measure |
Travatan
n=502 participants at risk
Travoprost (0.004%)
|
|---|---|
|
Eye disorders
Cataract
|
29.3%
147/502 • Number of events 195 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Eye disorders
Iris hyperpigmentation
|
29.5%
148/502 • Number of events 151 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Vascular disorders
Hypertension
|
16.5%
83/502 • Number of events 97 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Eye disorders
Visual acuity reduced
|
11.0%
55/502 • Number of events 73 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Eye disorders
Ocular hyperemia
|
10.0%
50/502 • Number of events 56 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.6%
38/502 • Number of events 41 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Injury, poisoning and procedural complications
Injury
|
5.0%
25/502 • Number of events 26 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Eye disorders
Dry eye
|
5.0%
25/502 • Number of events 28 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.2%
26/502 • Number of events 27 • Baseline to 5 years.
Adverse events were both volunteered and solicited.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60