A Phase 4 interventional study of Use of bromfenac 0.09% to reduce intravitreal injection pain and Use of artificial tears to reduce intravitreal injection pain in Pain, Intravitreal Injection and Pain, Acute, sponsored by Wills Eye. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Wills Eye · Phase 4, Interventional, and Treatment
The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.
This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 97 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Wills Eye is the lead sponsor of 77 studies on the registry; 2 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Compared within Acute Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria are:
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
Drug: Use of artificial tears to reduce intravitreal injection pain
The eyedrop (bromfenac) will be given to the assigned eye.
The eyedrop (artificial tears) will be given to the assigned eye.
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Time frame: Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Patients will be asked to report their pain on the Wong-Baker Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level.
Time frame: Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Time frame: Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
from 0 through 10, in which 10 is the worst pain level.
Time frame: Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Patients will be asked to report their pain on the Short Form McGill Pain Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Time frame: Patients will be called for their rating 24 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
from 0 through 10, in which 10 is the worst pain level.
Time frame: Patients will be called for their rating 24 hours after injection
Plan to share: Yes — Only de-identified data will be shared amongst researchers.
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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