Low incidence of iris pigmentation and eyelash changes in 2 randomized clinical trials with unoprostone isopropyl 0.15%.
OBJECTIVE
To assess whether iris color and eyelash changes occur with the use of unoprostone for 2 years.


METHODS
The 2 clinical trials described herein were prospective, randomized, double-masked, active-controlled, parallel group, multicenter studies.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
McCarey
Bernard E
BE
Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA.
Kapik
Barry M
BM
Kane
Frances E
FE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015784:Betaxolol / Q000009:adverse effects / Q000627:therapeutic use; D015237:Dinoprost / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005127:Eye Color / Q000187:drug effects*; D005140:Eyelashes / Q000187:drug effects*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006200:Hair Color / Q000187:drug effects*; D006801:Humans; D017495:Hyperpigmentation / Q000139:chemically induced* / Q000453:epidemiology; D015994:Incidence; D007429:Intraocular Pressure / Q000187:drug effects; D007498:Iris / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use; D010781:Photography; D013999:Timolol / Q000009:adverse effects / Q000627:therapeutic use
D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; C072630:isopropyl unoprostone; D013999:Timolol; D015237:Dinoprost; D015784:Betaxolol