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Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery

Information source: Discover Vision Centers
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract; Retinal Edema; Inflammation

Intervention: Prolensa (bromfenac 0.07%) (Drug); Ilevro (nepafenac 0.3%) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Melissa Toyos, MD

Official(s) and/or principal investigator(s):
Melissa Toyos, MD, Principal Investigator, Affiliation: Toyos Clinic

Overall contact:
Melissa Toyos, MD, Phone: 6153274015, Email: mtoyos@toyosclinic.com

Summary

To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.

Clinical Details

Official title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD for Treatment of Ocular Inflammation Associated With Cataract Surgery

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

Primary outcome: Treatment of inflammation associated with cataract surgery

Secondary outcome: Visual Acuity

Detailed description: To investigate the clinical outcomes for inflammation, visual acuity and macular thickness after treatment with Prolensa (bromfenac ophthalmic solution) 0. 07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are male or female at least 18 years of age who require cataract surgery and no other

surgical procedures 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.

- Are able to self administer test article (or have a caregiver available to instill

all doses of test article). Exclusion Criteria:

- Have known hypersensitivity to bromfenac, nepafenac, loteprednol or 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 NSAIDs (nonsteroidal

antiinflammatory drug).

- Have intraocular inflammation (i. e., cells or flare in the anterior chamber as

measured on slit lamp examination) in study eye at 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 study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.

- Have used ocular prostaglandins within 30 days prior to initiation of dosing with

test article or throughout the duration of study.

- Have active corneal pathology noted in the study eye at 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 study eye.

- Have any extraocular/intraocular inflammation in the study eye at screening visit

(blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis.

- 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.

- Have a history of abuse of alcohol/drugs within six months prior to the screening

visit.

- Are pregnant or nursing/lactating.

- Have participated in any other study of an investigational drug or device within 30

days prior to randomization.

Locations and Contacts

Melissa Toyos, MD, Phone: 6153274015, Email: mtoyos@toyosclinic.com

Toyos Clinic, Nashville, Tennessee 37203, United States; Recruiting
Melissa Toyos, MD, Phone: 615-327-4015, Email: mtoyos@toyosclinic.com
Melissa Toyos, MD, Phone: 6153274015, Email: mtoyos@toyosclinic.com
Melissa Toyos, MD, Principal Investigator
Additional Information

Starting date: April 2013
Last updated: June 10, 2015

Page last updated: August 23, 2015

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