Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
NCT ID: NCT07090044
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
77 participants
INTERVENTIONAL
2021-08-20
2022-12-08
Brief Summary
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\- 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Artificial Tears
Propylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection.
Propylene 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.
Bromfenac
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.
Bromfenac 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.
Loteprednol
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.
Loteprednol 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.
Interventions
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Bromfenac 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.
Loteprednol 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.
Propylene 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Retina Research Institute, LLC
OTHER
Responsible Party
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Principal Investigators
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Sabin Dang, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Research Institute, LLC
Locations
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The Retina Institute
St Louis, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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19928
Identifier Type: -
Identifier Source: org_study_id
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