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

Retina Research Institute, LLC

Status and phase: Completed; Phase 4

Conditions: Macular Degeneration Choroidal Neovascularization; Macular Edema; Vein Occlusion; Diabetic Retinopathy

Treatments: Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Drug: Bromfenac Sodium 0.07%; Drug: Propylene Glycol Preservative-free Artificial Tears

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07090044

19928

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 3 patient groups, including a placebo group

Bromfenac

Active Comparator group

Description:

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.

Treatment:

Drug: Bromfenac Sodium 0.07%

Loteprednol

Active Comparator group

Description:

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.

Treatment:

Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Artificial Tears

Placebo Comparator group

Description:

Propylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection.

Treatment:

Drug: Propylene Glycol Preservative-free Artificial Tears