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Local Anesthetic
Eyelid Lesion Removal for Local Anesthesia
Phase 4
Waitlist Available
Led By Robert Kersten, MD
Research Sponsored by University of California, San Francisco
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 10 minutes
Awards & highlights
No Placebo-Only Group
Approved for 20 Other Conditions
Drug Has Already Been Approved
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial is testing if bacteriostatic saline can provide the same pain relief as traditional anesthesia but with less pain during injection for patients having minor eyelid procedures. Bacteriostatic saline has been shown to reduce injection-associated pain and has been used effectively in periocular injections.
Eligible Conditions
- Local Anesthesia
- Eyelid Papilloma
- Eye Care
- Stye
- Ptosis
- Eyelid Tumors
- Eyelid Abscess
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain of procedure
Pain
Secondary study objectives
Additional Anesthesia
Bleeding level
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bacteriostatic Saline as Local AnesthesiaExperimental Treatment2 Interventions
Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Group II: Lidocaine with Epinephrine as Local AnesthesiaActive Control2 Interventions
Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.9% Bacteriostatic Local Anesthetic Injection
2022
Completed Phase 4
~100
Eyelid Lesion Removal
2022
Completed Phase 4
~100
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,583 Previous Clinical Trials
15,083,971 Total Patients Enrolled
Robert Kersten, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
401 Total Patients Enrolled
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