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

Primary Purpose

Cataract, Pseudoexfoliation Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Dexamethasone+Tobramycin eye drop
Bromfenac eye drop
Sponsored by
Arcispedale Santa Maria Nuova-IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dexamethasone+Tobramycin eye drop

Bromfenac

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with central macular thickness greater than 300 microns
Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).
Proportion of subjects with best corrected visual acuity equal to 20/20
Proportion of patients who had no ocular pain

Full Information

First Posted
May 12, 2014
Last Updated
October 28, 2014
Sponsor
Arcispedale Santa Maria Nuova-IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT02137161
Brief Title
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
Acronym
REPEX
Official Title
The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcispedale Santa Maria Nuova-IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Pseudoexfoliation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone+Tobramycin eye drop
Arm Type
Active Comparator
Arm 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.
Arm Title
Bromfenac
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone+Tobramycin eye drop
Intervention Description
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Bromfenac eye drop
Other Intervention Name(s)
Yellox
Intervention Description
bromfenac ophthalmic solution 0.09%
Primary Outcome Measure Information:
Title
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
Description
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.
Time Frame
Baseline, Day 3
Secondary Outcome Measure Information:
Title
Proportion of patients with central macular thickness greater than 300 microns
Description
Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).
Time Frame
Baseline, Week 4
Title
Proportion of subjects with best corrected visual acuity equal to 20/20
Time Frame
Baseline, Week 1
Title
Proportion of patients who had no ocular pain
Time Frame
Baseline, Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Coassin, MD PhD
Organizational Affiliation
Arcispedale S. Maria Nuova IRCCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Fontana, MD PhD
Organizational Affiliation
Arcispedale S. Maria Nuova IRCCS
Official's Role
Study Chair
Facility Information:
Facility Name
Arcispedale Santa Maria Nuova IRCSS - Ophthalmology
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy

12. IPD Sharing Statement

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

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