NCT07090044

Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Retina Research Institute, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn how various topical drops (bromfenac, loteprednol, and artificial tears) fare in alleviating post-intravitreal injection pain. The main questions it aims to answer are: \- Do bromfenac sodium and/or loteprednol etabonate improve post-injection pain scores compared to preservative-free artificial tears? Participants will: * Receive one drop of the topical drops five minutes prior to their regularly scheduled intravitreal injection. Depending on the treatment arm, they will also administer drops on their own at home up to 3 times per day on the day of their procedure. * They will answer a standardized pain score survey at 4 hours and 24 hours following their intravitreal injection and convey their results to study coordinators by phone.

Conditions

• Vein Occlusion
• Macular Degeneration Choroidal Neovascularization
• Macular Edema
• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Bromfenac Sodium 0.07%	Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as one topical drop, one time 5 minutes prior to the regularly scheduled standard of care intravitreal injection.
DRUG	Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly	Loteprednol etabonate 0.38% ophthalmic gel is a steroidal drug to be administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection.
DRUG	Propylene Glycol Preservative-free Artificial Tears	Propylene Glycol Preservative-free Artificial Tears is a placebo compartor administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection.

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-12-07
• Completion: 2022-12-08
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study