Conditions: Inflammation Pseudophakia
Keywords: NSAID Ocular Inflammation bromfenac
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Detailed description:
Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.

Arms:
arm 1: Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively. arm 2: Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginning 3 days prior to cataract surgery, on the day of surgery and for 21 days postoperatively in addition to usual cataract procedure.

Interventions: intervention 1: Bromfenac intervention 2: Nepafenac
Intervention descriptions: intervention 1: bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery intervention 2: nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery

Protocol document: