Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Discover Vision Centers.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Discover Vision Centers
ClinicalTrials.gov Identifier:
NCT01310127
First received: March 1, 2011
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Inflammation
Pseudophakia
Drug: Bromfenac
Drug: Nepafenac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Discover Vision Centers:

Primary Outcome Measures:
  • Optical Coherence Tomography (OCT) measurements of retinal thickness and volume. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    An assessment of retinal thickness and volume


Secondary Outcome Measures:
  • Summed ocular inflammation score (SOIS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    An assessment of the cells and flare, signs of inflammation in ocular tissue

  • ETDRS logMAR Visual Acuity [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    An assessment of visual acuity


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromday Drug: Bromfenac
bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Other Name: Bromday (bromfenac ophthalmic solution) 0.9%
Active Comparator: Nevanac Drug: Nepafenac
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
Other Name: Nevanac (nepafenac ophthamic suspension) 0.1%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310127

Locations
United States, Missouri
Discover Vision Centers
Independence, Missouri, United States, 64055
Sponsors and Collaborators
Discover Vision Centers
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Melissa Cable, MD Discover Vision Centers
  More Information

No publications provided

Responsible Party: Melissa Cable, M.D., Discover Vision Centers
ClinicalTrials.gov Identifier: NCT01310127     History of Changes
Other Study ID Numbers: MAC-02-11
Study First Received: March 1, 2011
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Discover Vision Centers:
NSAID
Ocular Inflammation
bromfenac

Additional relevant MeSH terms:
Inflammation
Pseudophakia
Pathologic Processes
Signs and Symptoms
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013