Document Detail

Low incidence of iris pigmentation and eyelash changes in 2 randomized clinical trials with unoprostone isopropyl 0.15%.
MedLine Citation:
PMID:  15288975     Owner:  NLM     Status:  MEDLINE    
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.
Bernard E McCarey; Barry M Kapik; Frances E Kane;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Ophthalmology     Volume:  111     ISSN:  0161-6420     ISO Abbreviation:  Ophthalmology     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-08-03     Completed Date:  2004-08-10     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1480-8     Citation Subset:  IM    
Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA.
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MeSH Terms
Aged, 80 and over
Antihypertensive Agents / adverse effects*,  therapeutic use
Betaxolol / adverse effects,  therapeutic use
Dinoprost / adverse effects*,  analogs & derivatives*,  therapeutic use
Double-Blind Method
Eye Color / drug effects*
Eyelashes / drug effects*
Glaucoma, Open-Angle / drug therapy*
Hair Color / drug effects*
Hyperpigmentation / chemically induced*,  epidemiology
Intraocular Pressure / drug effects
Iris / drug effects
Middle Aged
Ocular Hypertension / drug therapy
Ophthalmic Solutions / adverse effects,  therapeutic use
Timolol / adverse effects,  therapeutic use
Reg. No./Substance:
0/Antihypertensive Agents; 0/Ophthalmic Solutions; 26839-75-8/Timolol; 551-11-1/Dinoprost; 63659-18-7/Betaxolol; 69553-75-9/isopropyl unoprostone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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