NCT06130384

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Intravitreal Injection
• Pain, Acute

Interventions

Type	Name	Description
DRUG	Use of bromfenac 0.09% to reduce intravitreal injection pain	The eyedrop (bromfenac) will be given to the assigned eye.
DRUG	Use of artificial tears to reduce intravitreal injection pain	The eyedrop (artificial tears) will be given to the assigned eye.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-08-15
• Completion: 2023-11-15
• First posted: 2023-11-14
• Last updated: 2024-02-09

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study