NCT01452009

Brief Summary

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Status
withdrawn

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

October 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

October 12, 2011

Last Update Submit

February 9, 2012

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

open angle glaucomaocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Efficacy: mean IOP Efficacy as measured by mean IOP

    3 months

Study Arms (2)

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

EXPERIMENTAL
Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation)

TRAVATAN®

ACTIVE COMPARATOR

TRAVATAN® administered one drop once daily

Drug: TRAVATAN®

Interventions

Travoprost Ophthalmic Solution, 0.004% (New Formulation)DRUG

Travoprost Ophthalmic Solution, 0.004% given one drop once daily

Travoprost Ophthalmic Solution, 0.004% (New Formulation)
TRAVATAN®DRUG

TRAVATAN® administered one drop once daily

TRAVATAN®

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older
  • Either gender
  • Any race/ethnicity
  • Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

You may not qualify if:

  • Patients with any form of glaucoma other than open-angle glaucoma.
  • Patients with a central cornea thickness greater than 620 μm
  • Patients with Shaffer angle Grade \< 2
  • Patients with a cup/disc ratio greater than 0.80
  • Patients with severe central visual field loss
  • Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
  • Chronic, recurrent or severe inflammatory eye disease
  • Clinically significant or progressive retinal disease
  • Other ocular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors
0

Study Design

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

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 14, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 10, 2012

Record last verified: 2012-02