Safety Study of DuoTrav APS in Patients With Open-Angle G... | NCT00928590

Studies
Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT00928590

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

155Actual

Phase

Phase 3

Conditions

Open-angle Glaucoma
Ocular Hypertension

Interventions

Travoprost/Timolol Maleate Fixed Combination solution

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

ID	Type	Description	Link
EudraCT Number 2009-013178-42

Status Module

Record Verification Date

Jul 2014

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

Jul 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 25, 2009

First Posted Date

Jun 26, 2009Estimated

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

Jul 16, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 16, 2014

Certification/Extension First Posted Date

Jul 18, 2014Estimated

Last Update Submitted Date

Jul 16, 2014

Last Update Posted Date

Jul 18, 2014Estimated

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

The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

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

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DuoTrav APS	Experimental	Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months	Drug: Travoprost/Timolol Maleate Fixed Combination solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost/Timolol Maleate Fixed Combination solution	Drug		DuoTrav APS	DuoTrav APS DuoTrav (POLYQUAD-preserved)

Measure	Description	Time Frame
Adverse Events (AEs)		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to sign an informed consent document.
Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
Stable treatment of an IOP-lowering medication.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Pregnant, breastfeeding, or not using adequate birth control.
Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
Other protocol-defined exclusion criteria may apply.

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
Theresa Landry, Ph.D	Alcon Research	Study Director

Locations

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
C571754	Duotrav

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided