Clinical trial NCT01847638: Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Retinal Edema
Inflammation
Keywords: Retinal edema
Cataract
inflammation
Lead sponsor: Toyos Clinic
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2013-05-07
Enrollment: 50
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: To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.

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 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.

Primary outcomes:
measure: Treatment of Inflammation Associated With Cataract Surgery
timeFrame: change from baseline to final at post op 42 days +/-7 days
Secondary outcomes:
measure: Visual Acuity
timeFrame: baseline score to final postoperative visit at 42 days +/-7 days
Other outcomes:
measure: Retinal Thickness
timeFrame: change from baseline to final postoperative visit at 42 days +/- 7 days
Locations:
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
Study officials:
affiliation: Toyos Clinic
name: Melissa Toyos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toyos MM. Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification. Ophthalmol Ther. 2019 Jun;8(2):261-270. doi: 10.1007/s40123-019-0174-x. Epub 2019 Mar 13.