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A 12-Week Study

Hiromu K. Mishima, MD; Kanjiro Masuda, MD; Yoshiaki Kitazawa, MD; Ikuo Azuma, MD; Makoto Araie, MD

Arch Ophthalmol. 1996;114(8):929-932.

Abstract
Objective
To evaluate the intraocular pressure (IOP)-reducing effect and the side effects of latanoprost (PhXA41), a new phenyl-substituted prostaglandin F₂-isopropyl ester analogue, in patients with elevated IOP, using timolol maleate as the reference drug.

Methods
A total of 184 patients with primary open-angle glaucoma or ocular hypertension at 35 medical centers participated in this randomized double-masked study. The patients were randomized to receive either 0.005% latanoprost once daily or 0.5% timolol maleate twice daily, for a period of 12 weeks. Intraocular pressure was measured 24 hours after the administration of timolol, at 2, 4, 8, and 12 weeks of treatment.

Results
Latanoprost reduced IOP at the end of 12 weeks by 6.2±2.7 mm Hg (mean±SD) (26.8%), while timolol reduced IOP by 4.4±2.3 mm Hg (19.9%). At all visits latanoprost reduced IOP significantly more than timolol did. The main ocular side effects observed in both groups were conjunctival hyperemia and smarting. The main systemic side effect was a reduced pulse rate, which occurred in patients treated with timolol.

Conclusions
The results of this study demonstrated that 0.005% latanoprost taken once daily is well tolerated and more effective in reducing IOP than 0.5% timolol taken twice daily. Thus, latanoprost may become an important choice for the medical treatment of glaucoma.

Author Affiliations
From the Departments of Ophthalmology, Hiroshima University, Hiroshima (Dr Mishima), Tokyo University, Tokyo (Drs Masuda and Araie), Gifu University, Gifu (Dr Kitazawa), and Osaka Medical College, Osaka (Dr Azuma), Japan. The authors do not have any financial or proprietary interest in the products mentioned.

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