Tolerability and toxicity of topically applied nepafenac 0.3% compared with generic ketorolac 0.5.

PURPOSE: To compare patient-reported tolerability, impact on quality of life, interference with activities of daily life, and ocular surface toxicity of branded nepafenac 0.3% and generic ketorolac 0.5% after cataract surgery.

SETTING

Harvard Eye Associates, Laguna Hills, California, and the Cincinnati Eye Institute, Ohio, USA.

DESIGN

Prospective case series.

METHODS

One eye of each patient was randomized to receive ketorolac 0.5% or nepafenac 0.3% topical eyedrops for 3 days preoperatively and 28 days postoperatively. Additional medications were moxifloxacin 0.5% 4 times a day 3 days preoperatively and 7 days postoperatively and difluprednate 0.05% twice a day for 1 week postoperatively. Primary endpoints were patient-reported tolerability of each drug, the related impact on quality of life, and activities of daily life. Secondary endpoints were differences in conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining.

RESULTS

Baseline characteristics were similar between the nepafenac group (n = 91) and the ketorolac group (n = 90). Burning and stinging lasted longer in the ketorolac group, while blurry/hazy/foggy vision and a film or coating on the eye lasted longer in the nepafenac group (all P < .0001). All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows: corneal staining (64% versus 28%); Oxford grade 2 or greater staining (28% versus 4%); Schulze grade 30 or greater conjunctival erythema (65% versus 36%, respectively); abnormal TBUT greater than 10 seconds (77% versus 51%) (all P < .0001).

CONCLUSION

Branded nepafenac 0.3%-treated patients had significantly better objective and subjective outcomes after cataract surgery than generic ketorolac 0.5%-treated patients.