Clinical trial of diclofenac sodium (Naclof) eye drops on Nigerians.

Author(s): Onakoya AO, Majekodunmi AA, Adefule-Ositelu AO, Alimi HL, Akinsola FB, Aribaba OT

Affiliation(s): Ophthalmology unit, Department of Surgery, College of Medicine University of Lagos.

Publication date & source: 2004-12, Niger Postgrad Med J., 11(4):265-8.

Publication type: Clinical Trial; Randomized Controlled Trial

Twenty-eight eyes of 26 age-matched patients who had planned extracapsular cataract extraction with or without intraocular lens implantation were enrolled into a double blind randomised actively controlled study of 2 groups. Each group of 14 eyes was assigned to receive 0.1% diclofenac sodium (Naclof) eye drops or 1% prednisolone acetate eye suspension. The patients received either 0.1% Diclofenac sodium eye drops or 1.0% prednisolone acetate eye suspension four times a day as their post operative anti-inflammatory medication for a period of four weeks. No significant difference was noticed in the subjective assessment of pain and conjunctival injection in the 28 days follow-up period except day 1 in the diclofenac sodium group (0.05> p >0.01). Other measured objective variables of inflammation such as anterior chamber cells and flare showed no significant difference from the 3rd-28th postoperative days (0.05< p > 0.20). The result demonstrated that 0.1% diclofenac sodium eye drops was as effective as 1% prednisolone acetate eye suspension in the control of postoperative inflammation after cataract surgery, and could serve as a viable alternative to topical steroids in Nigerians who are steroid responders.