Three Month Safety and Efficacy Study of TRAVATAN® Versus... | NCT01452009

Studies
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

NCT01452009

Sponsor

Alcon Research

Status

Withdrawn

Last Update Posted

Feb 10, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Open Angle Glaucoma
Ocular Hypertension

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Management Decision

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 12, 2011

First Submission Date that Met QC Criteria

Oct 13, 2011

First Posted Date

Oct 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2012

Last Update Posted Date

Feb 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: mean IOP Efficacy as measured by mean IOP		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069557	Travoprost

Ancestor Terms

ID	Term
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins

Browse Leaves

Not provided

Browse Branches

Not provided