Phase II placebo-controlled study of nepafenac ophthalmic suspension 0.1% for postoperative inflammation and ocular pain associated with cataract surgery in Japanese patients

Abstract

ObjectiveThis study aimed to examine the efficacy and safety of nepafenac ophthalmic suspension compared to placebo in the management of postoperative inflammation and ocular pain in Japanese patients undergoing cataract surgery.MethodsThis was a multicenter, randomized, double-masked, placebo-controlled clinical study. Patients received nepafenac or placebo TID beginning 1 day before cataract surgery and continuing on the day of surgery for 14 days. One additional drop was administered on the day of surgery. The primary efficacy variables were the percentage of patients cured at postoperative day 14 visit (cure defined as aqueous cells score + aqueous flare score = 0) and the percentage of patients who were pain free at all postoperative visits.ResultsThe cure rate on day 14 after surgery was 71.4% (75/105) in the nepafenac group and 28.6% (30/105) in the placebo group, showing a significant difference in cure rate between groups. The nepafenac group demonstrated higher cure rates than those in the placebo group, with a significant difference in cure rate on days 7 and 14 postoperatively. The ocular pain-free rate was 96.2% (102/106) in the nepafenac group and 67.6% (71/105) in the placebo group, showing a significant difference between groups. Concerning adverse events (AEs), 26 AEs were reported in 21 subjects (19.6%) in the nepafenac group and 31 AEs were reported in 24 subjects (22.4%) in the placebo group.ConclusionNepafenac ophthalmic suspension is a nonsteroidal anti-inflammatory drug effective in the prevention of postoperative inflammation and ocular pain associated with cataract surgery.

Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use

“…Both are effective in resolving postoperative inflammation and pain, increasing patient comfort, and decreasing the risk of complications [1, 7–11]. NSAIDs act through inhibition of cyclooxygenase enzymes, thereby blocking the production of prostaglandins [12].…”

Pain Following the Use of Anesthesia Formulation Among Individuals Undergoing Cataract Surgery: A Randomized Controlled Trial

“…Clinical signs of increased prostaglandins production, except pain, include inflammation, which is classically treated with steroids and nonsteroidal anti-inflammatory drugs (NSAIDs) (Kohnen, 2015). Numaga et al found that 0.1% nepafenac seems to be a safe and efficacious ophthalmic suspension for postoperative inflammation and eye pain following cataract surgery or other ophthalmic procedures (Numaga et al, 2012). On the other hand, Ogurel et al evaluated analgesic effectiveness and patient satisfaction of 0.1% nepafenac in patients who underwent bilateral cataract surgery with VAS and VPS (Oğurel et al, 2018).…”

Effect of Nepafenac Eye Drops on Pain Associated With Pterygium Surgery

“…Similarly, the authors who used nepafenac in photorefractive keratectomy (PRK) and cataract surgery concluded that topical nepafenac was safe and effective to perform topical analgesia. [9][10][11][12] The control of pain originating from the cornea and/or conjunctiva is a problem for the patients undergoing surgeries related to ocular surface, such as pterygium surgery, refractive surgery, and strabismus surgery. There are many techniques and methods described for the management of postoperative pain.…”

“…7,8 Nepafenac (Nevanac; Alcon, Turkey) has been used to control the pain after many ocular surgeries. [9][10][11][12] It is unique among ophthalmic NSAIDs in that it is a prodrug deaminated to amfenac, a highly effective nonselective COX inhibitor. 13 It has superior corneal permeability characteristics compared with other available topical NSAIDs that minimize surface complications often observed with topical NSAIDs 14 and has been proven to have an acceptably great margin of safety.…”

“…13 It has superior corneal permeability characteristics compared with other available topical NSAIDs that minimize surface complications often observed with topical NSAIDs 14 and has been proven to have an acceptably great margin of safety. 11 To our knowledge, the effectiveness of topical NSAIDs has not been investigated to control the pain after pterygium surgery. This study was designed to determine the effectiveness of nepafenac ophthalmic suspension 0.1% for the control of pain experienced after pterygium surgery.…”