Trial intelligence / Profile preview

Bacteriostatic saline for minor eyelid procedures

NCT05294640Phase 4

Key facts

Status: Completed
Start: May 2022
Primary completion: Feb 2023
Countries: 1
Sponsor: University of California, San Francisco
Modality: Injectable Hydrogels, Small Molecules

Drugs: bacteriostatic sodium chloride
Conditions: Eyelid tumorhordeolumchalazionEyelid MalpositionEyelid abscess

Overview

Phase 4, randomised trial of bacteriostatic sodium chloride in Eyelid tumor, hordeolum, chalazion and 3 more (2 arms), sponsored by University of California, San Francisco. Primary endpoints: Pain on Injection at 5 minutes and Pain of Procedure at 10 minutes. Started May 2022; status: completed.

Design

2 arms

Study design: Randomized

Bacteriostatic Saline
Patients receiving bacteriostatic saline as local anesthesia.
Lidocaine with Epinephrine
Patients receiving lidocaine with epinephrine as local anesthesia.

Who it enrols

Adults aged 18 or older undergoing clinic-based periocular procedures without additional sedation and no allergies to the study drugs.

Endpoints

Primary

Pain on Injection5 minutes
Pain of Procedure10 minutes

Secondary

Number of Lesions That Needed Additional Anesthesia to Complete Procedure10 minutes
Bleeding Level10 minutes

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