NCT00293761

Brief Summary

The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension

Trial Health

100
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

February 17, 2006

Last Update Submit

November 17, 2016

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

open-angleglaucomaocularhypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IOP

Study Arms (2)

Travatan, Investigational

EXPERIMENTAL
Drug: Travoprost, Investigational

Travatan

ACTIVE COMPARATOR
Drug: Travoprost (TRAVATAN)

Interventions

Travoprost, InvestigationalDRUG

One drop in study eye once daily for 13 days

Travatan, Investigational
Travoprost (TRAVATAN)DRUG

One drop in study eye once daily for 13 days

Also known as: TRAVATAN
Travatan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.

You may not qualify if:

  • Under age 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gross RL, Peace JH, Smith SE, Walters TR, Dubiner HB, Weiss MJ, Ochsner KI. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008 Apr-May;17(3):217-22. doi: 10.1097/IJG.0b013e31815a3472.

    PMID: 18414108RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucomaHypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Eye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

November 18, 2016

Record last verified: 2012-03