NCT00789646

Brief Summary

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

November 11, 2008

Last Update Submit

March 10, 2019

Conditions

Corneal Ulcer

Keywords

corneal ulcerpainlesssubconjunctival injectionantibioticsantifungallidocaine

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale

    immediately after injection

Secondary Outcomes (1)

  • Side effects

    24 hours after injection

Study Arms (2)

NSS/Lidocaine

EXPERIMENTAL

First injection: Normal saline Second injection: 2% Lidocaine without adrenaline

Procedure: NSS/Lidocaine

Lidocaine/NSS

EXPERIMENTAL

First injection: 2% Lidocaine without adrenaline Second injection: Normal saline

Procedure: Lidocaine/NSS

Interventions

Lidocaine/NSSPROCEDURE

First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection

Lidocaine/NSS
NSS/LidocainePROCEDURE

First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection

NSS/Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.
  • corneal epithelial defect with stromal infiltration
  • reaction in anterior chamber
  • positive for bacteria or fungus
  • The patients have to receive subconjunctival antibiotic injection twice at least.
  • The patients must be informed consent.

You may not qualify if:

  • The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
  • The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
  • Unable to cooperate with the treatment.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

March 12, 2019

Record last verified: 2019-03