Clinical trial NCT01310127: Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%
Official title: Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Treatment of Ocular Inflammation Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Pseudophakia
Keywords: NSAID
Ocular Inflammation
bromfenac
Lead sponsor: Toyos Clinic
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-03-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.

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.

Primary outcomes:
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
timeFrame: Week 6
measure: Summed Ocular Inflammation Score (SOIS)
timeFrame: Week 6
measure: OCT Retinal Thickness
timeFrame: Week 6
measure: Macular Volume
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Discover Vision Centers
name: Melissa Cable, MD
role: PRINCIPAL_INVESTIGATOR
References: