Overview

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

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arcispedale Santa Maria Nuova-IRCCS
Treatments:
BB 1101
Bromfenac
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Tetrahydrozoline
Tobramycin
Criteria
Inclusion Criteria:

- cataract

- pseudoexfoliation syndrome

Exclusion Criteria:

- history of ocular inflammation or trauma

- previous intraocular surgery

- corneal haze

- retinal vascular disease

- diabetic retinopathy

- variation of the foveal profile at OCT (macular edema, epiretinal membrane)

- moderate to severe age related macular degeneration