Trial | NCT03317847  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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).
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 Started
Oct 16
2017
Primary Completion
Jun 14
2018
Study Completion
Dec 21
2018
Last Update
Jun 03
2019

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

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.

Bromfenac Experimental

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

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

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
No Results Posted