NCT02137161

Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery

The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution). DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial. PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31). INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons. Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.

Conditions

• Cataract
• Pseudoexfoliation Syndrome

Interventions

Type	Name	Description
DRUG	Dexamethasone+Tobramycin eye drop	dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
DRUG	Bromfenac eye drop	bromfenac ophthalmic solution 0.09%

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-13
• Last updated: 2025-06-11

Locations

1 site across 1 country: Italy