Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%
Condition: Inflammation; Pseudophakia
MeSH terms: Inflammation; Pseudophakia
Intervention: Bromfenac; Nepafenac
Intervention description: bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery; nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Intervention MeSH terms: Nepafenac; Bromfenac; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSAID; Ocular Inflammation; bromfenac

Summary:

      This is a single-center, randomized, investigator-masked, parallel group, and
      active-comparator controlled study investigating the clinical outcomes for visual acuity and
      macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or
      Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract
      extraction with posterior chamber intraocular lens implantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female at least 18 years of age who are scheduled for unilateral cataract
             surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens
             implantation and for whom no other ophthalmic surgical procedures (e.g., relaxing
             incisions, iridectomy, conjunctival excisions, etc) are to be conducted during the
             cataract surgery.

          -  Agree not to have any other ocular surgical procedures in the study or fellow (non
             study) eye within 15 days prior to the initiation of dosing with the test article or
             throughout the duration of the study.

          -  Have a Best Corrected Visual Acuity of 20/200 or better in either eye.

          -  If a woman capable of becoming pregnant, agree to have urine pregnancy testing
             performed at screening (must be negative) and agree to use a medically acceptable form
             of birth control throughout the study duration and for at least one week prior to and
             after completion of the study. Women considered capable of becoming pregnant include
             all females who have experienced menarche and who have not experienced menopause (as
             defined by amenorrhea for greater than 12 consecutive months) or have not undergone
             successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
             bilateral oophorectomy).

          -  Have IOP ≥ 5 mmHg and ≤ 22 mmHg (in study eye) with or without anti glaucoma therapy
             at the pre operative screening visit (if >22 mmHg, adjust following pachymetry).

        Exclusion Criteria:

          -  Have known hypersensitivity to bromfenac or Nepafenac or to any component of the test
             article (including "procedural" medications such as anesthetic and/or fluorescein
             drops, dilating drops, etc.).

          -  Have a known hypersensitivity to salicylates (i.e., aspirin) or to other non steroidal
             anti inflammatory drugs (NSAIDs).

          -  Have intraocular inflammation (i.e., cells or flare in the anterior chamber as
             measured on slit lamp examination) in the study eye at the screening visit.

          -  Have a known blood dyscrasia or bone marrow suppression, a diagnosis of
             uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative
             colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune,
             hepatic, renal, or central nervous system disease.

          -  Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic
             gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of
             dosing with the test article or throughout the duration of the study.

          -  Have used any ocular prostaglandins within 30 days prior to initiation of dosing with
             the test article or throughout the duration of the study.

          -  Have active corneal pathology noted in the study eye at the screening visit. Active
             corneal pathology is defined as corneal pathology that is non stable, or greater than
             mild, or will compromise assessment of the safety or efficacy of treatment.
             Superficial punctate keratitis in the study eye is a criterion for exclusion.

          -  Have used topical, ocular, inhaled or systemic steroids within 14 days prior to
             screening.

          -  Have had radial keratotomy, corneal transplant, or corneal refractive surgery in the
             study eye within the last two years.

          -  Are pregnant or nursing/lactating.