Abstract

Volume.116 Number.2

Original article : Clinical science

Phase III Open-label Study of Nepafenac Ophthalmic Suspension 0.1% for Inflammation and Ocular Pain Following Ophthalmic Surgery
Jiro Numaga1, Koji Yata2, Sanpei Miyake3, Isao Saito4, Nobuyuki Yabe5, Ken Hayashi6, Sumiyo Noge7, Kazunori Miyata8, Tsukasa Hanemoto9
1 Department of Ophthalmology, Tokyo Metropolitan Geriatric Hospital and Institute Gerontology
2 Yata Eye Clinic
3 Miyake Eye Hospital
4 Department of Ophthalmology, Kitano Hospital
5 Ohshima Hospital of Ophthalmology
6 Hayashi Eye Hospital
7 Department of Ophthalmology, Murakami Karindoh Hospital
8 Miyata Eye Hospital
9 Kozawa Eye Hospital and Diabetes Center

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: he 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.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 116: 86-94, 2012.

Key words
Nepafenac ophthalmic suspension, Postoperative inflammation, Ocular pain, Vitrectomy, Laser surgery
Reprint requests to
Jiro Numaga, M.D. Department of Ophthalmology, Tokyo Metropolitan Geriatric Hospital and Institute Gerontology. 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan