NCT00051168

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2003

Completed
3 years until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 12, 2010

Completed
Last Updated

October 7, 2011

Status Verified

April 1, 2010

Enrollment Period

3.2 years

First QC Date

January 3, 2003

Results QC Date

March 22, 2010

Last Update Submit

October 2, 2011

Conditions

Glaucoma, Open-angleOcular Hypertension

Keywords

GlaucomaPOAGOAGOHT

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Travatan

EXPERIMENTAL

Travoprost (0.004%)

Drug: Travatan

Interventions

TravatanDRUG

Travoprost (0.004%) 1 drop each eye once daily

Travatan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult patients of any race and either sex with chronic angle-closure glaucoma.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Europe

Fort Worth, Texas, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2003

First Posted

January 7, 2003

Study Start

January 1, 2006

Primary Completion

March 1, 2009

Last Updated

October 7, 2011

Results First Posted

April 12, 2010

Record last verified: 2010-04

Locations

US(1)