Phase III Safety and Efficacy Study to Evaluate a Glaucom... | NCT00288951

Studies
Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

NCT00288951

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Aug 17, 2012Estimated

Enrollment

690Actual

Phase

Phase 3

Conditions

Open-angle Glaucoma
Ocular Hypertension

Interventions

Travoprost 0.004% with and without BAK

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

Sep 2009

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

Oct 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Feb 7, 2006

First Submission Date that Met QC Criteria

Feb 7, 2006

First Posted Date

Feb 9, 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

Aug 16, 2012

Last Update Posted Date

Aug 17, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy 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

690Actual

Name	Type	Description	Arm Group Labels	Other Names
Travoprost 0.004% with and without BAK	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded.

Exclusion Criteria:

See Inclusion 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

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