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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabin Dang, MD | Retina Research Institute, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38437826 | Result | 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. | |
| 35887936 | Result | 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. |
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All IPD Collected throughout the trial
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| 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. |
|
| 22562296 | Result | 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. |
| 37691285 | Result | 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. |
| 27442130 | Result | 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. |
| 32199867 | Result | 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. |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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