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

NCT07090044 | Completed Phase 4 FDA Drug

• 1 other identifier: 19928
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intravitreal Injection; Post-procedure Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At 4 hours and 24 hours following intravitreal injection

Study Arms (3)

Bromfenac

ACTIVE COMPARATOR

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.

Drug: Bromfenac Sodium 0.07%

Loteprednol

ACTIVE COMPARATOR

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.

Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Artificial Tears

PLACEBO COMPARATOR

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

Drug: Propylene Glycol Preservative-free Artificial Tears

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.

Bromfenac

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.

Loteprednol

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.

Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Standard of Care Treatment with intravitreal injection

You may not qualify if:

• 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
• Current topical corticosteroid or non-steroidal anti-inflammatory drug (NSAID)

Sponsors & Collaborators

• Retina Research Institute, LLC: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Related Publications (6)

• SakallioGlu AK, Kaya S, GarIp R, Guclu H. COMPARISON OF THE EFFECTS OF EIGHT DIFFERENT TOPICAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS ON REDUCING INTRAVITREAL INJECTION-INDUCED PAIN. Retina. 2024 Jul 1;44(7):1196-1202. doi: 10.1097/IAE.0000000000004085.

  PMID: 38437826 BACKGROUND

• Lee DH, Kim M, Choi EY, Chin HS, Kim M. Efficacy of Pretreatment with Preservative-Free Topical Bromfenac in Improving Post-Intravitreal-Injection Pain: A Prospective Pilot Study. J Clin Med. 2022 Jul 18;11(14):4172. doi: 10.3390/jcm11144172.

  PMID: 35887936 BACKGROUND

• Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.

  PMID: 22562296 BACKGROUND

• Shtayer C, Lily Okrent Smolar A, Elmalak M, Abayev L, Grzybowski A, Moisseiev E. Post-Intravitreal injection pain reduction using topical NSAIDS: A comparative study. Eur J Ophthalmol. 2025 Sep;35(5):1703-1709. doi: 10.1177/11206721231201176. Epub 2023 Sep 10.

  PMID: 37691285 BACKGROUND

• Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.

  PMID: 27442130 BACKGROUND

• Popovic MM, Muni RH, Nichani P, Kertes PJ. Topical Nonsteroidal Anti-inflammatory Drugs for Pain Resulting from Intravitreal Injections: A Meta-Analysis. Ophthalmol Retina. 2020 May;4(5):461-470. doi: 10.1016/j.oret.2020.01.024. Epub 2020 Feb 13.

  PMID: 32199867 BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sabin Dang, MD

  Retina Research Institute, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: August 20, 2021
• Primary Completion: December 7, 2022
• Study Completion: December 8, 2022
• Last Updated: July 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)