A Long-term Safety Study of Once-daily Travatan

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00051168
• Collaborator: (none)
• Enrollment: 502
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-angle; Ocular Hypertension	Drug: Travatan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 502 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Safety Study of Once-daily TRAVATAN
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travatan Travoprost (0.004%)	Drug: Travatan; Travoprost (0.004%) 1 drop each eye once daily

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Adult patients of any race and either sex with chronic angle-closure glaucoma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Europe	Fort Worth	Texas	United States

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00051168
• Other Study ID Numbers: C-02-20
• First Posted: Jan 7, 2003
• Last Update Posted: Oct 7, 2011
• Last Verified: Apr 1, 2010

• Keywords provided by Alcon Research: Glaucoma; POAG; OAG; OHT
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Travoprost

Study Results

Participant Flow

Recruitment Details	Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.

Arm/Group Title	Travatan
Arm/Group Description	Travoprost (0.004%)
Period Title: Overall Study
STARTED	502
COMPLETED	367
NOT COMPLETED	135

Baseline Characteristics

Arm/Group Title	Travatan
Arm/Group Description	Travoprost (0.004%)
Overall Participants	502
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	237 47.2%
>=65 years	265 52.8%
Sex: Female, Male (Count of Participants)
Female	281 56%
Male	221 44%

Outcome Measures

1. Primary Outcome

Title	Mean Intraocular Pressure
Description	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.
Time Frame	At 5 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travatan
Arm/Group Description	Travoprost (0.004%)
Measure Participants	502
Mean (Standard Deviation) [millimeters mercury (mm Hg)]	16.5 (2.6)

Adverse Events

Time Frame	Baseline to 5 years.
Adverse Event Reporting Description	Adverse events were both volunteered and solicited.
Arm/Group Title	Travatan
Arm/Group Description	Travoprost (0.004%)
All Cause Mortality
	Travatan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Travatan
	Affected / at Risk (%)	# Events
Total	99/502 (19.7%)
Blood and lymphatic system disorders
Anaemia	1/502 (0.2%)	2
Cardiac disorders
Cardiac failure	1/502 (0.2%)	2
Cardiogenic shock	1/502 (0.2%)	1
Cardiopulmonary failure	1/502 (0.2%)	1
Cardio-respiratory arrest	2/502 (0.4%)	2
Myocardial infarction	3/502 (0.6%)	3
Acute coronary syndrome	1/502 (0.2%)	1
Angina pectoris	1/502 (0.2%)	1
Arrhythmia	1/502 (0.2%)	1
Atrial fibrillation	1/502 (0.2%)	1
Atrial flutter	1/502 (0.2%)	1
Bradycardia	1/502 (0.2%)	1
Coronary artery disease	1/502 (0.2%)	1
Eye disorders
Choroidal Neovascularisation	1/502 (0.2%)	1
Gastrointestinal disorders
Abdominal Pain	2/502 (0.4%)	2
Gastric haemorrhage	1/502 (0.2%)	1
Gastritis haemorrhagic	1/502 (0.2%)	1
Gastrointestinal disorder	1/502 (0.2%)	1
Intestinal obstruction	1/502 (0.2%)	1
Intestinal perforation	1/502 (0.2%)	1
Pancreatitis acute	1/502 (0.2%)	1
Umbilical hernia	1/502 (0.2%)	1
Hepatobiliary disorders
Hepatic failure	1/502 (0.2%)	1
Cholecystitis	1/502 (0.2%)	1
Cholelithiasis	1/502 (0.2%)	1
Infections and infestations
Pneumonia	4/502 (0.8%)	5
Respiratory tract infection	2/502 (0.4%)	2
Abscess	1/502 (0.2%)	1
Bronchitis	1/502 (0.2%)	1
Bronchopneumonia	1/502 (0.2%)	1
Cholecystitis infective	1/502 (0.2%)	1
Diverticulitis	1/502 (0.2%)	1
Gastrointestinal infection	1/502 (0.2%)	1
Infection	1/502 (0.2%)	1
Influenza	1/502 (0.2%)	1
Post procedural infection	1/502 (0.2%)	1
Urinary tract infection	1/502 (0.2%)	1
Injury, poisoning and procedural complications
Injury	8/502 (1.6%)	8
Postoperative thrombosis	1/502 (0.2%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/502 (0.2%)	1
Foot deformity	1/502 (0.2%)	1
Osteoarthritis	4/502 (0.8%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma	1/502 (0.2%)	1
Acute leukaemia	1/502 (0.2%)	1
Benign salivary gland neoplasm	1/502 (0.2%)	1
Bladder cancer	1/502 (0.2%)	1
Bladder neoplasm	1/502 (0.2%)	1
Breast cancer	3/502 (0.6%)	3
Colon cancer	2/502 (0.4%)	4
Gastric cancer	1/502 (0.2%)	2
Hypopharyngeal cancer stage III	1/502 (0.2%)	1
Laryngeal cancer	1/502 (0.2%)	1
Lung adenocarcinoma	1/502 (0.2%)	1
Lung neoplasm malignant	1/502 (0.2%)	1
Lymphoma	1/502 (0.2%)	1
Prostate cancer	3/502 (0.6%)	3
Prostatic adenoma	1/502 (0.2%)	1
Renal cancer	1/502 (0.2%)	1
Nervous system disorders
Cerebral haemorrhage	1/502 (0.2%)	1
Cerebrovascular accident	3/502 (0.6%)	5
Cluster headache	1/502 (0.2%)	1
Headache	1/502 (0.2%)	2
Syncope	1/502 (0.2%)	1
Visual field defect	1/502 (0.2%)	1
Psychiatric disorders
Depression	1/502 (0.2%)	1
Renal and urinary disorders
Renal failure	1/502 (0.2%)	1
Hydronephrosis	1/502 (0.2%)	1
Nephrotic syndrome	2/502 (0.4%)	2
Renal failure acute	1/502 (0.2%)	1
Urinary bladder polyp	1/502 (0.2%)	1
Urinary incontinence	1/502 (0.2%)	1
Reproductive system and breast disorders
Breast mass	1/502 (0.2%)	1
Uterine prolapse	1/502 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Pleural disorder	1/502 (0.2%)	1
Chronic obstructive pulmonary disease	1/502 (0.2%)	1
Dyspnoea	2/502 (0.4%)	2
Pulmonary embolism	1/502 (0.2%)	1
Skin and subcutaneous tissue disorders
Urticaria	1/502 (0.2%)	1
Surgical and medical procedures
Carotid endarterectomy	1/502 (0.2%)	1
Cataract operation	2/502 (0.4%)	2
Cholecystectomy	3/502 (0.6%)	3
Coronary artery bypass	1/502 (0.2%)	1
Hip arthroplasty	1/502 (0.2%)	1
Hip surgery	1/502 (0.2%)	1
Hysterectomy	1/502 (0.2%)	1
Inguinal hernia repair	2/502 (0.4%)	2
Knee arthroplasty	1/502 (0.2%)	1
Knee operation	1/502 (0.2%)	1
Lung operation	1/502 (0.2%)	1
Lymphadenectomy	1/502 (0.2%)	1
Spinal operation	1/502 (0.2%)	1
Trabeculoplasty	1/502 (0.2%)	2
Vascular disorders
Aortic aneurysm rupture	1/502 (0.2%)	1
Hypertension	1/502 (0.2%)	1
Hypotension	1/502 (0.2%)	1
Varicose vein	1/502 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Travatan
	Affected / at Risk (%)	# Events
Total	304/502 (60.6%)
Eye disorders
Cataract	147/502 (29.3%)	195
Iris hyperpigmentation	148/502 (29.5%)	151
Visual acuity reduced	55/502 (11%)	73
Ocular hyperemia	50/502 (10%)	56
Dry eye	25/502 (5%)	28
Injury, poisoning and procedural complications
Injury	25/502 (5%)	26
Metabolism and nutrition disorders
Hypercholesterolaemia	38/502 (7.6%)	41
Diabetes mellitus	26/502 (5.2%)	27
Vascular disorders
Hypertension	83/502 (16.5%)	97

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.