Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery

Abstract

Background: To compare nepafenac 0.1% with placebo and ketorolac 0.5% for prevention and treatment of ocular pain and inflammation after cataract surgery.

Methods: In a multi-center, randomized, placebo- and active-controlled, double-masked clinical trial, 227 patients with cataract were randomized to receive nepafenac 0.1%, ketorolac 0.5%, or placebo TID beginning 1 day pre-operatively and continuing for 21 days postoperatively. At each postoperative visit, cure rates and clinical success rates (</=5 aqueous cells and no flare) were calculated, and investigators evaluated patients' pain. On Day 7, patients judged ocular comfort after study drug instillation.

Results: Nepafenac 0.1% produced significantly more cures compared to placebo at Day 14 (76.3% vs 59.2%, p = 0.0241), more clinical successes from Day 7 onward (p < 0.05), and more pain-free patients from Day 3 onward (p < 0.05). Nepafenac 0.1% was superior to ketorolac 0.5% in terms of clinical success at Day 14 (p = 0.0319) and in percentage of pain-free patients at Day 3 (p = 0.0366). Nepafenac 0.1% also demonstrated less discomfort upon instillation than ketorolac 0.5% (p = 0.0158).

Conclusion: The anti-inflammatory efficacy of nepafenac 0.1% is better than that of placebo; it is also more comfortable and at least equal to ketorolac 0.5% in the prevention and treatment of postoperative ocular pain and inflammation.

Keywords: NSAIDs; cataract; inflammation; ketorolac; nepafenac.

Figure 1

Percentage of patients cured (no aqueous cells or flare) at Day 14 with nepafenac 0.1% or placebo. *p = 0.0241, chi-square test. Note: The number at the bottom of each bar represents the number of evaluable patients in each arm.

Figure 2

Cure rate of nepafenac 0.1%, ketorolac 0.5%, and placebo at each visit. *p = 0.0241, chi-square test. Note: The numbers at the bottom of the Day 1 bars represent the number of evaluable patients in each arm. The number of evaluable patients did not vary across time points.

Figure 3

Clinical success rate of nepafenac 0.1%, ketorolac 0.5%, and placebo at each visit. *nepafenac 0.1% vs placebo, chi-square test. ^†nepafenac 0.1% vs ketorolac 0.5%, chi-square test. Note: The numbers at the bottom of the Day 1 bars represent the number of evaluable patients in each arm. The number of evaluable patients did not vary across time points.

Figure 4

Pain-free rate of nepafenac 0.1%, ketorolac 0.5%, and placebo at each visit. *nepafenac 0.1% vs placebo, chi-square test. ^†nepafenac 0.1% vs ketorolac 0.5%, chi-square test. Note: The numbers at the bottom of the Day 1 bars represent the number of evaluable patients in each arm. The number of evaluable patients did not vary across time points.

Figure 5

Mean ocular discomfort of eye drops at Day 7. *p = 0.0158 nepafenac 0.1% vs ketorolac 0.5%, t-test, on a 0 to 5 scale. Note: The number at the bottom of each bar represents the number of evaluable patients in that arm. Sixteen patients had missing ocular discomfort scores, for a total of 209 evaluable patients.