Inflammation EyePhase 4BVDNCT03317847
Bromfenac Versus Dexamethasone After Cataract Surgery
A Phase 4 study testing Bromfenac 0.09 % Ophthalmic Solution and Dexamethasone 0.1% ophthalmic suspension in people with Inflammation Eye, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Inflammation Eye
- What is being tested?
- Bromfenac 0.09 % Ophthalmic Solution and Dexamethasone 0.1% ophthalmic suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2017to 21 Dec 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 year old.
- Uneventful cataract surgery. Surgical procedure, as described in the patients chart, should be free of any form of intraoperative complication that may increase postoperative inflammation.
- Availability of relevant ocular history, including: Best Corrected Visual Acuity testing, Laser Flare Photometry, Optical Coherence Tomography, slit lamp biomicroscopy, intraocular pressure (with pneumotonometer), dilated fundus ophthalmoscopy.
- Ability and willing to follow all instructions and attend all study visits
- Ability to self-administer study drug (or have a caregiver available to instill all doses of study drug)
- Ability and willing to provide informed consent for this study protocol.
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- No ocular, topical, systemic, or inhaled NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 1 week of investigational product initiation or throughout the duration of the study;
- No topical, inhaled, or systemic corticosteroids within 15 days or depot corticosteroids within 45 days of the investigational product initiation or or throughout the duration of the study;
- No oral tamsulosin at any time during the clinical trial;
- Any ocular, topical, or systemic medication that could interfere with normal lacrimation, wound healing, the investigational product, or the interpretation of clinical trial results.
- For women, the menopausal state is assumed.
Who cannot join
- Ocular exclusion criteria:
- history of ocular inflammation or trauma;
- history of previous intraocular surgery;
- corneal haze, edema or any condition that can interfere with LFP measurement by means of reduced transparency of the cornea;
- preoperative LFP value > 12 ph/ms (as per patient' chart)
- pseudoexfoliation lentis;
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- retinal vascular diseases;
- diabetic retinopathy;
- any variation of the foveal profile at OCT (including macular edema and epiretinal membranes)
- moderate to severe forms of age related macular degeneration
- presence of any sign of intraocular inflammation (including cells or flare in the anterior chamber) in either eye (including uveitis);
- intraoperative complications during the surgical procedure that may increase postoperative inflammation; this includes, in particular, patients with posterior capsule rupture;
- marked intraocular inflammation at postoperative day 1, including keratic precipitates or any form of uveitis;
- BCVA ≤ 1/10 in the non study eye
- Systemic exclusion criteria:
- inflammatory diseases;
- any active or chronic/recurrent disease that was uncontrolled and was likely to affect wound healing;
- severe blood dyscrasia or bone marrow suppression;
- uncontrolled/unstable peptic ulcer disease
- any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease;
- Known hypersensitivity to bromfenac or to any component of the investigational products, procedural medications, salicylates, or other NSAIDs.
- Patients cannot be enrolled in another clinical study concurrently
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: Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery
The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).
Read the detailed description
The BVD study is a phase IV, single centre, randomized, active-control, parallel design, open-label trial comparing Bromfenac ophthalmic solution 0.1% and Dexamethasone ophthalmic suspension 0.1% in patients older than 60 years after unilateral cataract surgery.
A total of 76 patients (38 for each arm) will be included in this study. Patients will be selected among subjects who underwent cataract surgery the day before the study enrolment. Enrolment will take place at the participating hospital.
Eligible subjects will be sequentially assigned, according to a computer-generated randomization list (1:1), to one of the following treatment groups:
- Experimental Arm: Bromfenac ophthalmic solution 0.1% eye drops, 2 times per day in the study eye for two weeks;
- Standard Arm: Dexamethasone ophthalmic suspension 0.1% eye drops, 4 times per day in the study eye for the first week and 2 times per day in the study eye for the second week.
Each group must start the drops the day after cataract surgery, for two weeks.
The first post-operative clinical evaluation is planned the day after cataract surgery. The following procedures will be performed on the study eye and data will be collected during this first clinical encounter:
- Eye Drops Usage training
- Concomitant medications
- Best-corrected Visual Acuity
- Laser Flare Photometry
- Slit lamp biomicroscopy
- Intracular pressure (IOP) with pneumotonometer,
- Dilated fundus ophthalmoscopy
- Ocular Comfort Grading Assessment
At least six post-operative follow-up visits are planned after 3, 7, 9, 11, 14 days (±1 day) and 30 days (±3 days) from cataract extraction plus possible adjunctive controls if problems/complications will occur. The following procedures will be performed on the study eye and data will be collected during all clinical encounters:
- Compliance with study medication
- Concomitant medications
- Best-corrected Visual Acuity (only day 7, 14, 30)
- Laser Flare Photometry
- Optical Coherence Tomography testing (only day 30)
- Slit lamp biomicroscopy (only day 7, 14 and 30)
- IOP with pneumotonometer (only day 7, 14 and 30)
- Dilated fundus ophthalmoscopy (only day 30)
- Ocular Comfort Grading Assessment (only day 7, 14 and 30)
- Adverse events
- Conditions
- Inflammation Eye
- Being tested
- Bromfenac 0.09 % Ophthalmic Solution, Dexamethasone 0.1% ophthalmic suspension
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac 0.09 % Ophthalmic SolutionDrug
Also called Yellox
Patients will self-administer 1 drop of Bromfenac twice daily to the affected eye beginning 1 day after cataract surgery and then continuing through the first 14 days of the postoperative period.
Dexamethasone 0.1% ophthalmic suspensionDrug
Patients will self-administer 1 drop of Dexamethasone to the study eye beginning 1 day after cataract surgery 4 times daily during the first postoperative week and 2 times daily in the second postoperative week.
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac | Experimental | Patients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks Receives: Drug: Bromfenac 0.09 % Ophthalmic Solution |
| Dexamethasone | Active comparator | Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week Receives: Drug: Dexamethasone 0.1% ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flare to baseline
Time needed to revert the postoperative flare (measured by laser flare meter in the anterior chamber of the eye) to the preoperative or lower level.
Measured: Within one month
Flare at day 14
Proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the two groups
Measured: 14 days
Secondary outcomes (3)
Best Corrected Visual Acuity (BCVA)
Proportion of subjects with BCVA equal to 10/10 at day 14 in the two groups
Measured: 14 days
Macular thickness at optical coherence tomography (OCT)
Proportion of patients with central macular thickness greater than 300 microns at day 30 in the two groups
Measured: 1 month
Ocular Comfort Grading Assessment (OCGA)
Safety endpoint: proportion of patients with no ocular discomfort at day 14. Ocular discomfort will be assessed by the OCGA scale. The OCGA measures 7 ocular symptoms (eye pain, tearing, itching, foreign body sensation, photophobia, eye discharge, haziness); at visits, patients will assess the severity by grading each symptom as none (0), mild (1), moderate (2), or severe (3)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start16 Oct 2017
- Primary completion14 Jun 2018
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammation EyeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 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, Santa Maria Nuova Hospital IRCCSLuigi Fontana, Study chair, Santa Maria Nuova Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317847
- Sponsor's protocol ID
- Eudract 2016-004358-14
- Acronym
- BVD
- Status last verified
- Jan 2019
- First submitted
- 19 Oct 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Maria M, Coassin M, Mastrofilippo V, Cimino L, Iannetta D, Fontana L. Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis. Adv Ther. 2020 Jul;37(7):3223-3233. doi: 10.1007/s12325-020-01383-1. Epub 2020 May 21.
PubMed 32440977Coassin M, De Maria M, Mastrofilippo V, Braglia L, Cimino L, Sartori A, Fontana L. Anterior Chamber Inflammation After Cataract Surgery: A Randomized Clinical Trial Comparing Bromfenac 0.09% to Dexamethasone 0.1. Adv Ther. 2019 Oct;36(10):2712-2722. doi: 10.1007/s12325-019-01076-4. Epub 2019 Sep 3.
PubMed 31482510
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery
- ClinicalTrials.gov ID
- NCT03317847
- Acronym / sponsor ID
- BVD / Eudract 2016-004358-14
- Conditions
- Inflammation Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).
Detailed description
The BVD study is a phase IV, single centre, randomized, active-control, parallel design, open-label trial comparing Bromfenac ophthalmic solution 0.1% and Dexamethasone ophthalmic suspension 0.1% in patients older than 60 years after unilateral cataract surgery.
A total of 76 patients (38 for each arm) will be included in this study. Patients will be selected among subjects who underwent cataract surgery the day before the study enrolment. Enrolment will take place at the participating hospital.
Eligible subjects will be sequentially assigned, according to a computer-generated randomization list (1:1), to one of the following treatment groups:
- Experimental Arm: Bromfenac ophthalmic solution 0.1% eye drops, 2 times per day in the study eye for two weeks;
- Standard Arm: Dexamethasone ophthalmic suspension 0.1% eye drops, 4 times per day in the study eye for the first week and 2 times per day in the study eye for the second week.
Each group must start the drops the day after cataract surgery, for two weeks.
The first post-operative clinical evaluation is planned the day after cataract surgery. The following procedures will be performed on the study eye and data will be collected during this first clinical encounter:
- Eye Drops Usage training
- Concomitant medications
- Best-corrected Visual Acuity
- Laser Flare Photometry
- Slit lamp biomicroscopy
- Intracular pressure (IOP) with pneumotonometer,
- Dilated fundus ophthalmoscopy
- Ocular Comfort Grading Assessment
At least six post-operative follow-up visits are planned after 3, 7, 9, 11, 14 days (±1 day) and 30 days (±3 days) from cataract extraction plus possible adjunctive controls if problems/complications will occur. The following procedures will be performed on the study eye and data will be collected during all clinical encounters:
- Compliance with study medication
- Concomitant medications
- Best-corrected Visual Acuity (only day 7, 14, 30)
- Laser Flare Photometry
- Optical Coherence Tomography testing (only day 30)
- Slit lamp biomicroscopy (only day 7, 14 and 30)
- IOP with pneumotonometer (only day 7, 14 and 30)
- Dilated fundus ophthalmoscopy (only day 30)
- Ocular Comfort Grading Assessment (only day 7, 14 and 30)
- Adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromfenac | Experimental | Drug: Bromfenac 0.09 % Ophthalmic SolutionPatients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks |
| Dexamethasone | Active comparator | Drug: Dexamethasone 0.1% ophthalmic suspensionPatients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 60 year old.
- Uneventful cataract surgery. Surgical procedure, as described in the patients chart, should be free of any form of intraoperative complication that may increase postoperative inflammation.
- Availability of relevant ocular history, including: Best Corrected Visual Acuity testing, Laser Flare Photometry, Optical Coherence Tomography, slit lamp biomicroscopy, intraocular pressure (with pneumotonometer), dilated fundus ophthalmoscopy.
- Ability and willing to follow all instructions and attend all study visits
- Ability to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Key exclusion criteria (22 listed)
- Ocular exclusion criteria:
- Systemic exclusion criteria:
- Known hypersensitivity to bromfenac or to any component of the investigational products, procedural medications, salicylates, or other NSAIDs.
- Patients cannot be enrolled in another clinical study concurrently
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 |
|---|---|---|
| Bromfenac 0.09 % Ophthalmic SolutionAlso: YelloxPatients will self-administer 1 drop of Bromfenac twice daily to the affected eye beginning 1 day after cataract surgery and then continuing through the first 14 days of the postoperative period. | Drug | Bromfenac |
| Dexamethasone 0.1% ophthalmic suspensionPatients will self-administer 1 drop of Dexamethasone to the study eye beginning 1 day after cataract surgery 4 times daily during the first postoperative week and 2 times daily in the second postoperative week. | Drug | Dexamethasone |
Primary outcome
Flare to baseline
Time frame: Within one month
Time needed to revert the postoperative flare (measured by laser flare meter in the anterior chamber of the eye) to the preoperative or lower level.
Flare at day 14
Time frame: 14 days
Proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the two groups
3 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: 14 days
Macular thickness at optical coherence tomography (OCT)
Time frame: 1 month
Ocular Comfort Grading Assessment (OCGA)
Time frame: 14 days
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 25 Jun 2025.
- Derived from this study: PubMed 32440977De Maria M, Coassin M, Mastrofilippo V, Cimino L, Iannetta D, Fontana L. Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis. Adv Ther. 2020 Jul;37(7):3223-3233. doi: 10.1007/s12325-020-01383-1. Epub 2020 May 21.
- Derived from this study: PubMed 31482510Coassin M, De Maria M, Mastrofilippo V, Braglia L, Cimino L, Sartori A, Fontana L. Anterior Chamber Inflammation After Cataract Surgery: A Randomized Clinical Trial Comparing Bromfenac 0.09% to Dexamethasone 0.1. Adv Ther. 2019 Oct;36(10):2712-2722. doi: 10.1007/s12325-019-01076-4. Epub 2019 Sep 3.
- Individual participant dataSharing planned: No
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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
Santa Maria Nuova Hospital IRCCS
Luigi Fontana study chair
Santa Maria Nuova Hospital 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 Bromfenac 0.09 % Ophthalmic Solution and Dexamethasone 0.1% ophthalmic suspension in people with Inflammation Eye, 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 11 inclusion and 22 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 25 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?
Flare to baseline (time frame: Within one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317847, which also lists 2 linked publications.
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 25 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.