Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

NCT03886779 | Completed Phase 4 FDA Drug

• 1 other identifier: BLMAIIT-02-13
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (nepafenac Ophthalmic Suspension) 0.3% QD with extra (pulse) dose on day of surgery for Treatment of Ocular Inflammation Associated with Cataract Surgery

Conditions

Treatment of Ocular Inflammation Associated With Cataract Surgery

Keywords

Post-Ocular Inflammation; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Outcome Change measured by Summed Ocular Inflammation Score (SOIS)

  50 Subjects are planned, 25 per treatment group who are undergoing planned cataract extraction with posterior chamber intraocular lens implantation to evaluate the non-inferiority of Prolensa and Ilevro when administering a pulse dose in each arm 1 hour prior to surgery. Outcome measure is defined as SIOS score of zero (no cell or flare) on day 15 (day one being the day prior to surgery, and for 14 days following surgery

  Day 1 through Day 15

Secondary Outcomes (4)

• Adverse Events

  42 Days

• Slit Lamp Biomicroscopy

  42 Days

• Intraocular Pressure

  42 Days

• Funduscopic Examination (Dilated)

  42 Days

Study Arms (2)

Prolensa (Bromfenac Ophthalmic Solution) 0.07%

ACTIVE COMPARATOR

Bausch and Lomb, Rochester, NJ Dose: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one days prior to surgery (Day 1), continue on the day of surgery plus 1 hour before surgery and for 14 days after surgery.

Drug: Bromfenac

Ilevro® (nepafenac ophthalmic suspension ) 0.3%

ACTIVE COMPARATOR

Alcon Laboratories, Inc., Fort Worth, TX Dose: Subjects will instill one drop of test article into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one day prior to surgery (Day 1), continue on the day of surgery plus1 hour before surgery and for 14 days after surgery.

Drug: Nepafenac

Interventions

Bromfenac DRUG

0.7 MG/ML \[Prolensa\]

Prolensa (Bromfenac Ophthalmic Solution) 0.07%

Nepafenac DRUG

3 MG/ML \[Ilevro\]

Ilevro® (nepafenac ophthalmic suspension ) 0.3%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are male or female at least 18 years of age who are scheduled for unilateral cataract surgery VIA phacoemulsification 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.
• Are willing/able to return for all required study visits.
• Are willing/able to follow instructions from the study investigator and his/her staff.
• Are able to self administer test article (or have a caregiver available to instill all doses of test article).
• 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 signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
• Have IOP ≥ 5 mmHg and ≤ 22 mmHg (in study eye) without anti glaucoma therapy at the pre operative screening visit (if \>22 mmHg, adjust following pachymetry)

You may not qualify if:

• 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 any extraocular/intraocular inflammation in the study eye noted at the 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.

Sponsors & Collaborators

• Silverstein Eye Centers: lead
• Bausch & Lomb Incorporated: collaborator
• Churchhill Communications: collaborator
• Statistics & Data Corporation: collaborator

Related Publications (1)

• Silverstein SM. Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose. Ophthalmol Ther. 2019 Dec;8(4):577-587. doi: 10.1007/s40123-019-00215-y. Epub 2019 Sep 24.

  PMID: 31552543 DERIVED

MeSH Terms

Interventions

bromfenac; nepafenac

Study Officials

• Steven M Silverstein, MD

  Silverstein Eye Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study is investigator-masked to treatment group assignment for the duration of the study. Should the masking need to be broken, the study staff may reveal the treatment to the Investigator. The date, time, and reason for the unmasking must be documented as soon as
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, randomized, investigator masked, parallel group, and active-comparator controlled study to evaluate the clinical outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% for the treatment of ocular inflammation associated with cataract surgery

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 22, 2019
• Study Start: October 30, 2013
• Primary Completion: February 15, 2017
• Study Completion: March 1, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: To Be Determined