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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07090044

Enrollment

Registered

2025-07-29

Start date

2021-08-20

Completion date

2022-12-08

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Intravitreal Injection, Post-procedure Pain

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.

Interventions

DRUGBromfenac 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.

DRUGLoteprednol 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.

DRUGPropylene 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026