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

Retina Research Institute, LLC77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Vein Occlusion Macular Degeneration Choroidal Neovascularization Macular Edema Diabetic Retinopathy

Interventions

Bromfenac Sodium 0.07%DRUG

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.

Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyDRUG

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.

Propylene Glycol Preservative-free Artificial TearsDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Visual Analog Scale Pain Score

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.

Time frame: At 4 hours and 24 hours following intravitreal injection