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

Azienda USL Reggio Emilia - IRCCS

Status and phase: Completed; Phase 4

Conditions: Pseudoexfoliation Syndrome; Cataract

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02137161

2013-002066-39

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Dexamethasone+Tobramycin eye drop

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone+Tobramycin eye drop

Bromfenac

Experimental group

Description:

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.

Treatment:

Drug: Bromfenac eye drop

Drug: Dexamethasone+Tobramycin eye drop