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OpenTrials
Completed

NCT Number: NCT07090044

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

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.

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Key information

Conditions

Vein Occlusion Cardiovascular Diseases Choroid Diseases Choroidal Neovascularization Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Macular Degeneration Choroidal Neovascularization Macular Edema Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Retina Institute

St Louis, Missouri, 63128, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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/Jelly

Drug

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 Tears

Drug

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.

Primary outcomes

  1. Visual Analog Scale Pain Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Retina Research Institute, LLC

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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