[Phase III open-label study of nepafenac ophthalmic suspension 0.1% for inflammation and ocular pain following ophthalmic surgery].

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.