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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130384
• Other study ID #: 012475
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: February 2024
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Intravitreal Injection
• Pain
• Pain, Acute

Intervention

Drug:
• Use of bromfenac 0.09% to reduce intravitreal injection pain
The eyedrop (bromfenac) will be given to the assigned eye.
• Use of artificial tears to reduce intravitreal injection pain
The eyedrop (artificial tears) will be given to the assigned eye.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Mid Atlantic Retina	Bethlehem	Pennsylvania
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Retina Consultants of San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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