TerminatedNCT00047554Updated May 15, 2013

Study of TRAVATAN in Subjects With Iris Pigmentation Changes

An observational study in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Terminated. Per ClinicalTrials.gov, last updated 2013-05-15.

Sponsored by Alcon Research · Observational

Why this study was terminated

Study objectives met

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 336
Sex: All

Study 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.

Conditions studied

Open-Angle Glaucoma
Ocular Hypertension

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Keywords

open-angle
glaucoma
ocular
hypertension
primary open-angle glaucoma
iris
pigmentation

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 336 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Inclusion criteria

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 criteria

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
Enrollment: 336 participants (actual)
Patient registry: No

Groups and cohorts

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

DrugTravoprost, 0.004% ophthalmic solution
Also known as: TRAVATAN®

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00047554
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Oct 18, 2002
Start date: May 2003
Primary completion: Jun 2012
Completion: Jun 2012
Last update: May 15, 2013

Study contacts

Theresa Landry, PhD

study director · Alcon Research

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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