Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Ocular Hypertension Clinical Trial

Official title:

A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00047554
• Other study ID #: C-01-79
• Status: Terminated
• Phase: Phase 4
• First received: October 8, 2002
• Last updated: May 13, 2013
• Start date: May 2003
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 336
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Travoprost, 0.004% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Iris Pigmentation from Baseline for Study Eye by Visit	As assessed by ocular photography	Baseline, Up to Year 5	Yes
Secondary	Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit	As assessed by ocular photography	Baseline, Up to Year 5	Yes