Bromfenac Versus Dexamethasone After Cataract Surgery
Condition: Inflammation Eye
MeSH terms: Cataract; Capsule Opacification; Inflammation
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Bromfenac 0.09 % Ophthalmic Solution; Dexamethasone 0.1% ophthalmic suspension
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Yellox
Intervention MeSH terms: Dexamethasone; Bromfenac; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment