A Phase 4 interventional study of Dexamethasone+Tobramycin eye drop and Bromfenac eye drop in Cataract and Pseudoexfoliation Syndrome, sponsored by Azienda USL Reggio Emilia - IRCCS. Completed at 1 site in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Phase 4, Interventional, and Treatment
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 92 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
An antibiotic and steroid eye drop association will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week, to 31 patients.
Drug: Dexamethasone+Tobramycin eye drop
Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients.
Drug: Dexamethasone+Tobramycin eye drop · Drug: Bromfenac eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
bromfenac ophthalmic solution 0.09%
Also known as: Yellox
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3.
Time frame: Baseline, Day 3
Proportion of patients with central macular thickness greater than 300 microns
Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).
Time frame: Baseline, Week 4
Proportion of subjects with best corrected visual acuity equal to 20/20
Time frame: Baseline, Week 1
Proportion of patients who had no ocular pain
Time frame: Baseline, Day 3
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Azienda USL Reggio Emilia - IRCCS