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

Not Applicable

Completed

• Conditions: Vein Occlusion; Macular Edema; Diabetic Retinopathy; Macular Degeneration Choroidal Neovascularization
• Interventions: Drug: Bromfenac Sodium 0.07%; Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Drug: Propylene Glycol Preservative-free Artificial Tears

• Registration Number: NCT07090044
• Lead Sponsor: Retina Research Institute, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-20
• Primary Completion: 2022-12-07
• Study Completion: 2022-12-08
• Status Verified: 2025-05
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Standard of Care Treatment with intravitreal injection
• History of at least 1 anti-VEGF injection in the 90 days prior to inclusion
• Less than 13 intravitreal injection in the 365 days prior to inclusion

Exclusion Criteria

• History of autoimmune disease, graft versus host disease, neurotrophic corneal disease, contact lens use, keratitis, fibromyalgia, uveitis, herpetic ocular disease
• Drug allergy to any drug components
• History of any ocular surgery in the 30 days prior to inclusion
• Current topical corticosteroid or non-steroidal anti-inflammatory drug (NSAID)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bromfenac	Bromfenac Sodium 0.07%	Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection.
Loteprednol	Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly	Loteprednol etabonate ophthalmic gel 0.38% is a steroidal drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection.
Artificial Tears	Propylene Glycol Preservative-free Artificial Tears	Propylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score	At 4 hours and 24 hours following intravitreal injection	A standardized Visual Analog Scale (VAS) pain score is collected at 4 hours and 24 hours following standard of care intravitreal injection. Patients are provided a VAS scale and receive a call from study coordinators to collect pain scores.

Trial Locations

Locations (1)

The Retina Institute; 🇺🇸 Saint Louis, Missouri, United States