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Clinical evaluation of dipivefrine hydrochloride ophthalmic solution for primary open-angle glaucoma and ocular hypertension. Comparison with epinephrine ophthalmic solution Ikuo Azuma 1 , Yoshiaki Kitazawa 2 , Masahiro Takase 3 , Yoshihiko Shiose 4 , Atsushi Sawada 5 , Tsuneo Tanaka 6 1Dept. of ophthalmol, Osaka Med Coll 2Dept of Ophthalmol, Gifu Univ Sch of Med 3Dept of Ophthalmol, Fac of Med, Univ of Tokyo 4Dev of Ophthalmol, Aichi Prefect Cent of Health Care 5Dept of Ophthalmol, Miyazaki Med Coll 6Sch of Health Sci, Fac of Med, Univ of Tokyo pp.1089-1106
Published Date 1986/9/15
DOI https://doi.org/10.11477/mf.1410209864

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  • Abstract
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We performed a well-controlled clinical evaluation of 0.04% and 0.1% dipivefrine hydrochloride ophthalmic solution (DE 016; lyophilized powder with solvent) in patients with primary open-angle glaucoma or ocular hypertension. We used 1.25% epinephrine ophthalmic solution as the standard drug.

A total of 253 cases were subjected to statistical analysis, of which 125 cases belonged to the low dose group and 128 cases to the high dose group.

The therapeutic effect was judged as effective or better in 76.5% in 0.04% DE-016 group, in 76.1% in 0.1% DE-016 group and in 76.8% in epinephrine group. No statistical significance was present among the three groups. The mean value of reduction of intraocular pressure was 0.90 mmHg, 2.4lmmHg and 1.72 mmHg respectively in each group listed above. Side effects were noted in 35.4% in 0.04% DE-016 group, 52.4% in 0.1% DE-016 group and 50.0% in epine-phrine group. As regards safety, significant differences were noted among each of the 3 groups. The order of safety was 0.04% DE-016, 0.1% DE-016 and epinephrine in the decreasing order.

The subjective impression of good or better was expressed by 63.3% of patients in 0.04% DE-016 group, 62.0% in (1.1% DE-016 group and 51.1% in epinephrine group. The order of tolerance was thus 0.04% DE-016, O. 1% DE-016 and epinephrine in the decreasing order. The present findings indicate that 0.04% and 0.1% DE -016 ophthalmic solutions promises to be of value in the treatment of primary open-angle glaucoma and ocular hypertension. They may be drugs of choice over topical epinephrine because of their better clinical effects and better tolerability.

Rinsho Ganka (Jpn J Clin Ophthalmol 40(9) : 1089-1106,1986


Copyright © 1986, Igaku-Shoin Ltd. All rights reserved.

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電子版ISSN 1882-1308 印刷版ISSN 0370-5579 医学書院

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