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

NCT ID: NCT02137161

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone+Tobramycin eye drop

Intervention Type: DRUG

dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

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.

Group Type: EXPERIMENTAL

Dexamethasone+Tobramycin eye drop

Intervention Type: DRUG

dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

Bromfenac eye drop

Intervention Type: DRUG

bromfenac ophthalmic solution 0.09%

Interventions

Dexamethasone+Tobramycin eye drop

dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

Intervention Type: DRUG

Bromfenac eye drop

bromfenac ophthalmic solution 0.09%

Intervention Type: DRUG

Other Intervention Names

Yellox

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Coassin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Arcispedale S. Maria Nuova IRCCS

Luigi Fontana, MD PhD

Role: STUDY_CHAIR

Arcispedale S. Maria Nuova IRCCS

Locations

Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Reggio Emilia, RE, Italy

Countries

Italy

Other Identifiers

2013-002066-39

Identifier Type: -

Identifier Source: org_study_id