NCT05069350

Brief Summary

comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

September 14, 2021

Last Update Submit

September 10, 2022

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • verbal pain numerical scaling

    11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain

    10 minutes

Study Arms (2)

bupivacaine 0.5%

EXPERIMENTAL
Drug: bupivacaine 0.5% and oxubuprocaine

oxybuprocaine

EXPERIMENTAL
Drug: bupivacaine 0.5% and oxubuprocaine

Interventions

bupivacaine 0.5% and oxubuprocaineDRUG

using each drug as surface anesthesia before intravitreal injections

bupivacaine 0.5%oxybuprocaine

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients between 30 to 70 years

You may not qualify if:

  • uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Ophthamology

Giza, Haram, 12513, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double blinded randomized syudy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 6, 2021

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)