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

Cataract Clinical Trial

— REPEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137161
• Other study ID #: 2013-002066-39
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2014
• Last updated: October 28, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Exfoliation Syndrome
• Pseudoexfoliation Syndrome
• Syndrome

Intervention

Drug:
• Dexamethasone+Tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
• Bromfenac eye drop
bromfenac ophthalmic solution 0.09%

Locations

Country	Name	City	State
Italy	Arcispedale Santa Maria Nuova IRCSS - Ophthalmology	Reggio Emilia	RE

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Proportion of subjects with best corrected visual acuity equal to 20/20		Baseline, Week 1	No
Secondary	Proportion of patients who had no ocular pain		Baseline, Day 3	No