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Bromfenac Versus Dexamethasone After Cataract Surgery (BVD)

Primary Purpose

Inflammation Eye

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Bromfenac 0.09 % Ophthalmic Solution

Dexamethasone 0.1% ophthalmic suspension

About this trial

This is an interventional treatment trial for Inflammation Eye

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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
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;
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

Sites / Locations

Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bromfenac

Dexamethasone

Arm Description

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

Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Best Corrected Visual Acuity (BCVA)

Proportion of subjects with BCVA equal to 10/10 at day 14 in the two groups

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

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)

Full Information

NCT ID

NCT03317847

First Posted

October 19, 2017

Last Updated

May 31, 2019

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT03317847

Brief Title

Bromfenac Versus Dexamethasone After Cataract Surgery

Acronym

BVD

Official Title

Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 16, 2017 (Actual)

Primary Completion Date

June 14, 2018 (Actual)

Study Completion Date

December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arcispedale Santa Maria Nuova-IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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

6. Conditions and Keywords

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

Inflammation Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bromfenac

Arm Type

Experimental

Arm Description

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

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week

Intervention Type

Drug

Intervention Name(s)

Bromfenac 0.09 % Ophthalmic Solution

Other Intervention Name(s)

Yellox

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 0.1% ophthalmic suspension

Intervention Description

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.

Primary Outcome Measure Information:

Title

Flare to baseline

Description

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.

Time Frame

Within one month

Title

Flare at day 14

Description

Proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the two groups

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Best Corrected Visual Acuity (BCVA)

Description

Proportion of subjects with BCVA equal to 10/10 at day 14 in the two groups

Time Frame

14 days

Title

Macular thickness at optical coherence tomography (OCT)

Description

Proportion of patients with central macular thickness greater than 300 microns at day 30 in the two groups

Time Frame

1 month

Title

Ocular Comfort Grading Assessment (OCGA)

Description

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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; 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Coassin, MD PhD

Organizational Affiliation

Santa Maria Nuova Hospital IRCCS

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luigi Fontana

Organizational Affiliation

Santa Maria Nuova Hospital IRCCS

Official's Role

Study Chair

Facility Information:

Facility Name

Arcispedale Santa Maria Nuova IRCSS - Ophthalmology

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32440977

Citation

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.

Results Reference

derived

PubMed Identifier

31482510

Citation

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.

Results Reference

derived

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Bromfenac Versus Dexamethasone After Cataract Surgery

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