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

NCT02137161 | Completed Phase 4

• 1 other identifier: 2013-002066-39
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

Study Arms (2)

Dexamethasone+Tobramycin eye drop

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.

Drug: Dexamethasone+Tobramycin eye drop

Bromfenac

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.

Drug: Dexamethasone+Tobramycin eye drop; Drug: Bromfenac eye drop

Interventions

Dexamethasone+Tobramycin eye drop DRUG

dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

Bromfenac; Dexamethasone+Tobramycin eye drop

Bromfenac eye drop DRUG

bromfenac ophthalmic solution 0.09%

Also known as: Yellox

Bromfenac

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cataract
• pseudoexfoliation syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Reggio Emilia, RE, 42123, Italy

Location

MeSH Terms

Conditions

Cataract; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Marco Coassin, MD PhD

  Arcispedale S. Maria Nuova IRCCS

  PRINCIPAL INVESTIGATOR

• Luigi Fontana, MD PhD

  Arcispedale S. Maria Nuova IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 13, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 11, 2025

Record last verified: 2014-10

Locations

IT (1)