Nippon Ganka Gakkai zasshi · 2012
[Phase III open-label study of nepafenac ophthalmic suspension 0.1% for inflammation and ocular pain following ophthalmic surgery].
Клиническое исследование III фазыАннотация на английскомСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Numaga Jiro, Yata Koji, Miyake Sanpei, Saito Isao, Yabe Nobuyuki, Hayashi Ken, Noge Sumiyo, Miyata Kazunori, Hanemoto Tsukasa
Аннотация
PURPOSE: To examine the efficacy and safety of nepafenac ophthalmic suspension 0.1% on postoperative inflammation and eye pain with intraocular surgery, other than cataract surgery.
PATIENTS AND METHODS: Patients scheduled to undergo vitreous surgery, trabeculectomy, laser iridotomy, laser trabeculoplasty and laser posterior capsulotomy were investigated in a multicenter, open-label study.
RESULTS: The total rate of patients cured in all the intraocular surgery methods was 85.6% (95/111), and that of the patients who were pain free was 91.0% (101/111). The rate cured by vitreous surgery was 80.4% (45/56), by laser iridotomy 93.3% (14/15) and by laser posterior capsulotomy was 94.6% (35/37). The rate of patients free from pain following vitreous surgery was 85.7% (48/56), laser iridotomy 100.0% (15/15) and by laser posterior capsulotomy was 94.6% (35/37). A total of 23 adverse events were reported in 22 patients (19.6%). Allergic conjunctivitis was observed in one patient (0.9%) as an adverse event, in which the relationship cannot be denied. This allergic conjunctivitis was mild and resolved after treatment.
CONCLUSION: Nepafenac ophthalmic suspension 0.1% is considered safe and efficious not only following cataract surgery but also for postoperative inflammation and eye pain in intraocular surgery.
PATIENTS AND METHODS: Patients scheduled to undergo vitreous surgery, trabeculectomy, laser iridotomy, laser trabeculoplasty and laser posterior capsulotomy were investigated in a multicenter, open-label study.
RESULTS: The total rate of patients cured in all the intraocular surgery methods was 85.6% (95/111), and that of the patients who were pain free was 91.0% (101/111). The rate cured by vitreous surgery was 80.4% (45/56), by laser iridotomy 93.3% (14/15) and by laser posterior capsulotomy was 94.6% (35/37). The rate of patients free from pain following vitreous surgery was 85.7% (48/56), laser iridotomy 100.0% (15/15) and by laser posterior capsulotomy was 94.6% (35/37). A total of 23 adverse events were reported in 22 patients (19.6%). Allergic conjunctivitis was observed in one patient (0.9%) as an adverse event, in which the relationship cannot be denied. This allergic conjunctivitis was mild and resolved after treatment.
CONCLUSION: Nepafenac ophthalmic suspension 0.1% is considered safe and efficious not only following cataract surgery but also for postoperative inflammation and eye pain in intraocular surgery.