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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Pseudoexfoliation Syndrome
• Intervention / Treatment: Drug: Dexamethasone+Tobramycin eye drop; Drug: Bromfenac eye drop

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • RE
    • Reggio Emilia, RE, Italy, 42123
      • Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone+Tobramycin eye drop; 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; dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
Experimental: Bromfenac; 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; dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension; Drug: Bromfenac eye drop; bromfenac ophthalmic solution 0.09%; Other Names: Yellox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with central macular thickness greater than 300 microns	Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).	Baseline, Week 4
Proportion of subjects with best corrected visual acuity equal to 20/20		Baseline, Week 1
Proportion of patients who had no ocular pain		Baseline, Day 3

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Marco Coassin, MD PhD, Arcispedale S. Maria Nuova IRCCS; Study Chair: Luigi Fontana, MD PhD, Arcispedale S. Maria Nuova IRCCS

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Uveal Diseases; Lens Diseases; Iris Diseases; Syndrome; Cataract; Exfoliation Syndrome; Physiological Effects of Drugs; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Bacterial Agents; Pharmaceutical Solutions; Dexamethasone; Ophthalmic Solutions; Tobramycin; Bromfenac; Tobramycin, Dexamethasone Drug Combination
• Other Study ID Numbers: 2013-002066-39