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Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
NCT01027611Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2009
- Primary completion
- Nov 2009
- Countries
- 1
- Sponsor
- Illinois Retina Associates
- Modality
- Small Molecules
- Conditions
- procedural pain
01
Overview
Phase 3, randomised, open-label trial of proparacaine and lidocaine 10% oropharyngeal spray in procedural pain (3 arms), sponsored by Illinois Retina Associates. Primary endpoint: Injection experience grade. Started Oct 2009; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Proparacaine
0.5% proparacaine hydrochloride drops
Proparacaine + Lidocaine
0.5% proparacaine hydrochloride drops + 4% lidocaine hydrochloride solution
Lidocaine Gel
3.5% lidocaine hydrochloride ophthalmic gel (Akten)
03
Endpoints
Primary
Injection experience grade
Secondary
Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging
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