Overview

This trial is active, not recruiting.

Conditions cataract, pseudoexfoliation syndrome
Treatments dexamethasone+tobramycin eye drop, bromfenac eye drop
Phase phase 4
Sponsor Arcispedale Santa Maria Nuova-IRCCS
Start date November 2013
End date November 2014
Trial size 62 participants
Trial identifier NCT02137161, 2013-002066-39

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
dexamethasone+tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
(Experimental)
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.
dexamethasone+tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
bromfenac eye drop Yellox
bromfenac ophthalmic solution 0.09%

Primary Outcomes

Measure
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
time frame: Baseline, Day 3

Secondary Outcomes

Measure
Proportion of patients with central macular thickness greater than 300 microns
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

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
Principal investigator Marco Coassin, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Arcispedale Santa Maria Nuova-IRCCS.