Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
open-angle, glaucoma, ocular, hypertension, primary open-angle glaucoma, iris, pigmentation
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.
Interventions
DRUGTravoprost, 0.004% ophthalmic solution
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Iris Pigmentation from Baseline for Study Eye by Visit | Baseline, Up to Year 5 | As assessed by ocular photography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit | Baseline, Up to Year 5 | As assessed by ocular photography |
Outcome results
None listed