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

Phase 4

Completed

• Conditions: Pain, Acute; Pain; Intravitreal Injection
• Interventions: Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain; Drug: Use of artificial tears to reduce intravitreal injection pain

• Registration Number: NCT06130384
• Lead Sponsor: Wills Eye

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-02-10
• Study Start: 2021-03-01
• Primary Completion: 2023-08-15
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Study Completion: 2023-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bromfenac 0.09%	Use of bromfenac 0.09% to reduce intravitreal injection pain	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.
Artificial Tear	Use of artificial tears to reduce intravitreal injection pain	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.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Retina Consultants of San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States