Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.

The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Acute; Intravitreal Injection
• Intervention / Treatment: Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain; Drug: Use of artificial tears to reduce intravitreal injection pain

Detailed Description

This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rebecca R Soares, MD; Phone Number: 215-928-3300; Email: rsoares@midatlanticretina.com
• Study Contact Backup: Name: Sunir J Garg, MD; Phone Number: 215-928-3300; Email: sgarg@midatlanticretina.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University of Toronto
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Mid Atlantic Retina
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
  • Texas
    • San Antonio, Texas, United States, 78240
      • Retina Consultants of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria are:

• Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
• Clinical indication of bilateral intravitreal anti-vascular endothelial growth factor (VEGF) injection as determined by the treating retina specialist for diseases such as age-related macular degeneration, choroidal neovascularization, diabetic macular edema, diabetic retinopathy, macular edema. proliferative retinopathy, or macular edema associated with retina vein occlusion.
• Age greater than 18
• Patient's that have had at least three prior injections in each eye

Exclusion criteria are:

• Prior ocular surgery (non-cataract)
• Herpetic eye disease
• Uncontrolled uveitis
• Active conjunctivitis, keratitis or keratopathy
• Current unilateral use of prescription eye drops.
• Allergy to NSAID

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bromfenac 0.09%; At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.	Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain; The eyedrop (bromfenac) will be given to the assigned eye.
Placebo Comparator: Artificial Tear; At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.	Drug: Use of artificial tears to reduce intravitreal injection pain; The eyedrop (artificial tears) will be given to the assigned eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score	Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.	Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale	Patients will be asked to report their pain on the Wong-Baker Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level.	Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.	Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.	Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale	from 0 through 10, in which 10 is the worst pain level.	Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.	Patients will be asked to report their pain on the Short Form McGill Pain Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.	Patients will be called for their rating 24 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale	from 0 through 10, in which 10 is the worst pain level.	Patients will be called for their rating 24 hours after injection

Collaborators and Investigators

• Sponsor: Wills Eye

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Bromfenac; Lubricant Eye Drops
• Other Study ID Numbers: 012475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only de-identified data will be shared amongst researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No