Study of TRAVATAN in Subjects With Iris Pigmentation Changes | NCT00047554

Studies
Study of TRAVATAN in Subjects With Iris Pigmentation Changes

NCT00047554

Sponsor

Alcon Research

Status

Terminated

Last Update Posted

May 15, 2013Estimated

Enrollment

336Actual

Phase

Not provided

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

Travoprost, 0.004% ophthalmic 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

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study objectives met

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 8, 2002

First Submission Date that Met QC Criteria

Oct 17, 2002

First Posted Date

Oct 18, 2002Estimated

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

May 13, 2013

Last Update Posted Date

May 15, 2013Estimated

Description Module

Brief Summary

The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TRAVATAN		Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years	Drug: Travoprost, 0.004% ophthalmic solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost, 0.004% ophthalmic solution	Drug		TRAVATAN	TRAVATAN®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Iris Pigmentation from Baseline for Study Eye by Visit	As assessed by ocular photography	Baseline, Up to Year 5

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit	As assessed by ocular photography	Baseline, Up to Year 5

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
Has experienced an iris pigmentation change while dosing with TRAVATAN;
Currently dosing with TRAVATAN;
Other protocol-defined inclusion criteria may apply.

Exclusion:

Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
Not currently using TRAVATAN;
Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
History of any severe ocular pathology (including severe dry eye);
Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients were identified and enrolled from 23 investigational centers in the US.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Theresa Landry, PhD	Alcon Research	Study Director

Condition Browse Module

MeSH Terms

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

Ancestor Terms

ID	Term
D005128	Eye Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069557	Travoprost
D009883	Ophthalmic Solutions

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided