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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be asked in the office for their pain rating 5 minutes after injection
Awards & highlights
Study Summary
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.
Eligible Conditions
- Acute Pain
- Intravitreal Injections
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be asked in the office for their pain rating 5 minutes after injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be asked in the office for their pain rating 5 minutes after injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bromfenac 0.09%Experimental Treatment1 Intervention
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.
Group II: Artificial TearPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Use of bromfenac 0.09% to reduce intravitreal injection pain
2021
Completed Phase 4
~100
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Who is running the clinical trial?
Wills EyeLead Sponsor
79 Previous Clinical Trials
10,339 Total Patients Enrolled
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