Examining The Efficacy, Safety And Improved Tolerability... | NCT00444665

Studies
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy

NCT00444665

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 21, 2016Estimated

Enrollment

750Estimated

Phase

Phase 4

Conditions

Glaucoma

Interventions

Travatan-Z

Countries

United States

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

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Mar 7, 2007

First Submission Date that Met QC Criteria

Mar 7, 2007

First Posted Date

Mar 8, 2007Estimated

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

Nov 18, 2016

Last Update Posted Date

Nov 21, 2016Estimated

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

Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Name	Type	Description	Arm Group Labels	Other Names
Travatan-Z	Drug

Measure	Description	Time Frame
Ocular Surface Disease Symptoms

Measure	Description	Time Frame
Intraocular pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye)

Exclusion Criteria:

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Jasek, PhD	Alcon Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fridley		Fridley	Minnesota	55432	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19668762	Result	Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008 Sep;2(3):613-21. doi: 10.2147/opth.s3881.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

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