CataractPhase 4REPEXNCT02137161
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
A Phase 4 study testing Dexamethasone+Tobramycin eye drop and Bromfenac eye drop in people with Cataract and Pseudoexfoliation Syndrome, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cataract, Pseudoexfoliation Syndrome
- What is being tested?
- Dexamethasone+Tobramycin eye drop and Bromfenac eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract
- pseudoexfoliation syndrome
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Arcispedale Santa Maria Nuova IRCSS - Ophthalmology
Reggio Emilia, RE, 42123
About this study
Official title: The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
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.
Read more
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
- Being tested
- Dexamethasone+Tobramycin eye drop, Bromfenac eye drop
- Medical subject headings
- Cataract, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone+Tobramycin eye dropDrug
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
Bromfenac eye dropDrug
Also called Yellox
bromfenac ophthalmic solution 0.09%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone+Tobramycin eye drop; Drug: Bromfenac eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 3
Secondary outcomes (3)
Proportion of patients with central macular thickness greater than 300 microns
Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).
Measured: Baseline, Week 4
Proportion of subjects with best corrected visual acuity equal to 20/20
Measured: Baseline, Week 1
Proportion of patients who had no ocular pain
Measured: Baseline, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marco Coassin, MD PhD, Principal investigator, Arcispedale S. Maria Nuova IRCCSLuigi Fontana, MD PhD, Study chair, Arcispedale S. Maria Nuova IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137161
- Sponsor's protocol ID
- 2013-002066-39
- Acronym
- REPEX
- Status last verified
- Oct 2014
- First submitted
- 12 May 2014
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
- ClinicalTrials.gov ID
- NCT02137161
- Acronym / sponsor ID
- REPEX / 2013-002066-39
- Conditions
- Cataract, Pseudoexfoliation Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone+Tobramycin eye drop | Active comparator | Drug: Dexamethasone+Tobramycin eye dropAn 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 | Experimental | Drug: Dexamethasone+Tobramycin eye drop, Drug: Bromfenac eye dropBromfenac 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cataract
- pseudoexfoliation syndrome
Key exclusion criteria (7 listed)
- history of ocular inflammation or trauma
- previous intraocular surgery
- corneal haze
- retinal vascular disease
- diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone+Tobramycin eye dropdexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension | Drug | Bromfenac, Dexamethasone+Tobramycin eye drop |
| Bromfenac eye dropAlso: Yelloxbromfenac ophthalmic solution 0.09% | Drug | Bromfenac |
Primary outcome
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
Time frame: Baseline, Day 3
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.
3 secondary outcomes
Proportion of patients with central macular thickness greater than 300 microns
Time frame: Baseline, Week 4
Proportion of subjects with best corrected visual acuity equal to 20/20
Time frame: Baseline, Week 1
Proportion of patients who had no ocular pain
Time frame: Baseline, Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Coassin, MD PhD principal investigator
Arcispedale S. Maria Nuova IRCCS
Luigi Fontana, MD PhD study chair
Arcispedale S. Maria Nuova IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone+Tobramycin eye drop and Bromfenac eye drop in people with Cataract and Pseudoexfoliation Syndrome, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond) (time frame: Baseline, Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.