Low incidence of iris pigmentation and eyelash changes in 2 randomized clinical trials with unoprostone isopropyl 0.15%☆
The findings in this article were presented in part at: American Academy of Ophthalmology annual meeting, October 20–23, 2002; Orlando, Florida.
Received 25 November 2002; accepted 10 November 2003.
Abstract
Objective
To assess whether iris color and eyelash changes occur with the use of unoprostone for 2 years.
Design
The 2 clinical trials described herein were prospective, randomized, double-masked, active-controlled, parallel group, multicenter studies.
Participants
A total of 1131 patients with primary open-angle glaucoma or ocular hypertension participated in 2 clinical trials and received either unoprostone isopropyl 0.15% (659), timolol maleate 0.5% (331), or betaxolol hydrochloride 0.5% (141), 1 drop per eye twice daily for up to 24 months.
Methods
Color photographs (1:1 magnification) were taken of the iris and eyelid of each patient at baseline and at regular intervals thereafter through month 24 using a standardized camera system. Photography included 7 views of each eye plus a calibration photograph and a patient identification photograph, for a total of 16 photographs per patient per visit. Two independent (masked) readers subjectively compared baseline iris colors to subsequent visits. Side view photographs of the upper and lower eyelashes were used for the eyelash length analysis, with each having sufficient depth of field and a sufficient number of eyelashes in focus. Similarly, frontal eyelash views were used for the eyelash density analysis.
Main outcome measures
Changes from baseline in iris color and eyelash length and density within and between treatment groups.
Results
Seven cases of iris color change (1.06%) were confirmed in patients treated with unoprostone for up to 24 months; no confirmed cases were reported in the timolol or betaxolol groups. In the unoprostone group, cases of iris color change were confirmed at months 12 (1 case), 18 (2 cases), and 24 (4 cases). No clinically relevant differences were observed among treatment groups for changes from baseline in eyelash length or density.
Conclusion
Although iris hyperpigmentation and abnormal eyelash changes may occur after treatment with unoprostone, the incidence of these events appears to be low in the 2-year clinical study.
1Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA
This publication was sponsored by Novartis Ophthalmics, the marketing entity for unoprostone 0.15% ophthalmic solution (Rescula). The first author of this report received compensation for his involvement but has no proprietary or stock interest in Novartis Ophthalmics.
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