Bromfenac Versus Dexamethasone After Cataract Surgery

NCT03317847 | Completed Phase 4

• 1 other identifier: Eudract 2016-004358-14
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Inflammation Eye

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  14 days

Secondary Outcomes (3)

• Best Corrected Visual Acuity (BCVA)

  14 days

• Macular thickness at optical coherence tomography (OCT)

  1 month

• Ocular Comfort Grading Assessment (OCGA)

  14 days

Study Arms (2)

Bromfenac

EXPERIMENTAL

Patients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks

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

Drug: Dexamethasone 0.1% ophthalmic suspension

Interventions

Bromfenac 0.09 % Ophthalmic Solution DRUG

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.

Also known as: Yellox

Bromfenac

Dexamethasone 0.1% ophthalmic suspension DRUG

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.

Dexamethasone

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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
• inflammatory diseases;
• any active or chronic/recurrent disease that was uncontrolled and was likely to affect wound healing;

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Reggio Emilia, RE, 42123, Italy

Location

Related Publications (2)

• 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.

  PMID: 32440977 DERIVED

• Coassin 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.

  PMID: 31482510 DERIVED

MeSH Terms

Conditions

Endophthalmitis

Interventions

bromfenac; Ophthalmic Solutions; Dexamethasone

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marco Coassin, MD PhD

  Santa Maria Nuova Hospital IRCCS

  PRINCIPAL INVESTIGATOR

• Luigi Fontana

  Santa Maria Nuova Hospital IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 23, 2017
• Study Start: October 16, 2017
• Primary Completion: June 14, 2018
• Study Completion: December 21, 2019
• Last Updated: June 25, 2025

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)