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

NCT ID: NCT01847638

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-01
• Study Completion Date: 2018-08-23

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.

Conditions

Cataract; Retinal Edema; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prolensa (bromfenac 0.07%)

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Group Type: ACTIVE_COMPARATOR

Prolensa (bromfenac 0.07%)

Intervention Type: DRUG

Comparison 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

Ilevro (nepafenac 0.3%)

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Group Type: ACTIVE_COMPARATOR

Ilevro (nepafenac 0.3%)

Intervention Type: DRUG

Comparison 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

Interventions

Prolensa (bromfenac 0.07%)

Comparison 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

Intervention Type: DRUG

Ilevro (nepafenac 0.3%)

Comparison 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

Intervention Type: DRUG

Other Intervention Names

bromfenac ophthalmic solution 0.07%; nepafenac ophthalmic suspension 0.3%

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Melissa Toyos

OTHER

Sponsor Role: lead

Responsible Party

Melissa Toyos

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Melissa Toyos, MD

Role: PRINCIPAL_INVESTIGATOR

Toyos Clinic

Locations

Toyos Clinic

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30868419 (View on PubMed)

Other Identifiers

MMT-2013

Identifier Type: -

Identifier Source: org_study_id