A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma... | NCT00293761

Studies
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT00293761

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

109Actual

Phase

Phase 3

Conditions

Open-angle Glaucoma
Ocular Hypertension

Interventions

Travoprost, Investigational
Travoprost (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

Mar 2012

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

Jan 2006

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Feb 17, 2006

First Submission Date that Met QC Criteria

Feb 17, 2006

First Posted Date

Feb 20, 2006Estimated

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 17, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Description Module

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

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

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Travatan, Investigational	Experimental		Drug: Travoprost, Investigational
Travatan	Active Comparator		Drug: Travoprost (TRAVATAN)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost, Investigational	Drug	One drop in study eye once daily for 13 days	Travatan, Investigational

Measure	Description	Time Frame
Mean IOP

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Under age 18.
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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18414108	Result	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.

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension
D005901	Glaucoma
D006973	Hypertension

ID	Term
D005128	Eye Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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