Bromfenac Versus Dexamethasone After Cataract Surgery (BVD)

June 20, 2025 updated by: Azienda USL Reggio Emilia - IRCCS

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

  1. Age > 60 year old.
  2. 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.
  3. 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.
  4. Ability and willing to follow all instructions and attend all study visits
  5. Ability to self-administer study drug (or have a caregiver available to instill all doses of study drug)
  6. Ability and willing to provide informed consent for this study protocol.
  7. 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;
  8. 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;
  9. No oral tamsulosin at any time during the clinical trial;
  10. Any ocular, topical, or systemic medication that could interfere with normal lacrimation, wound healing, the investigational product, or the interpretation of clinical trial results.
  11. For women, the menopausal state is assumed.

EXCLUSION CRITERIA

  1. Ocular exclusion criteria:

    1. history of ocular inflammation or trauma;
    2. history of previous intraocular surgery;
    3. corneal haze, edema or any condition that can interfere with LFP measurement by means of reduced transparency of the cornea;
    4. preoperative LFP value > 12 ph/ms (as per patient' chart)
    5. pseudoexfoliation lentis;
    6. retinal vascular diseases;
    7. diabetic retinopathy;
    8. any variation of the foveal profile at OCT (including macular edema and epiretinal membranes)
    9. moderate to severe forms of age related macular degeneration
    10. presence of any sign of intraocular inflammation (including cells or flare in the anterior chamber) in either eye (including uveitis);
    11. intraoperative complications during the surgical procedure that may increase postoperative inflammation; this includes, in particular, patients with posterior capsule rupture;
    12. marked intraocular inflammation at postoperative day 1, including keratic precipitates or any form of uveitis;
    13. BCVA ≤ 1/10 in the non study eye

  2. Systemic exclusion criteria:

    1. inflammatory diseases;
    2. any active or chronic/recurrent disease that was uncontrolled and was likely to affect wound healing;
    3. severe blood dyscrasia or bone marrow suppression;
    4. uncontrolled/unstable peptic ulcer disease
    5. any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease;
  3. Known hypersensitivity to bromfenac or to any component of the investigational products, procedural medications, salicylates, or other NSAIDs.
  4. Patients cannot be enrolled in another clinical study concurrently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bromfenac
Patients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks
Drug: Bromfenac 0.09 % Ophthalmic Solution
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.
Other Names:
  • Yellox
Active Comparator: Dexamethasone
Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week
Drug: Dexamethasone 0.1% ophthalmic suspension
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within one month
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
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: 14 days
Proportion of subjects with BCVA equal to 10/10 at day 14 in the two groups
14 days
Macular thickness at optical coherence tomography (OCT)
Time Frame: 1 month
Proportion of patients with central macular thickness greater than 300 microns at day 30 in the two groups
1 month
Ocular Comfort Grading Assessment (OCGA)
Time Frame: 14 days
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)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda USL Reggio Emilia - IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco Coassin, MD PhD, Santa Maria Nuova Hospital IRCCS
  • Study Chair: Luigi Fontana, Santa Maria Nuova Hospital IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Eudract 2016-004358-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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