Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

NCT01027611 | Completed Phase 3

• 1 other identifier: jsp-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.

Conditions

Pain

Keywords

Effectiveness of topical pain medicine for control of pain associated with intravitreal injections; Eye discomfort

Outcome Measures

Primary Outcomes (1)

• Injection experience "grade"

  Outcome data is obtained approximately 10 seconds after conclusion of procedure

Secondary Outcomes (1)

• Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging

  Outcome data is obtained approximately 10 seconds after conclusion of procedure

Study Arms (3)

proparacaine HCL 0.5%

EXPERIMENTAL

Drug: proparacaine HCL 0.5%

proparacaine + lidocaine

EXPERIMENTAL

Drug: proparacaine HCL 0.5% + 4% lidocaine solution

lidocaine gel

EXPERIMENTAL

Drug: 3.5% viscous lidocaine gel

Interventions

proparacaine HCL 0.5% DRUG

proparacaine HCL 0.5%

proparacaine HCL 0.5% + 4% lidocaine solution DRUG

proparacaine + lidocaine

3.5% viscous lidocaine gel DRUG

lidocaine gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring intravitreal injection for treatment of eye disease

You may not qualify if:

• Eye infection
• Retinal detachment
• Age less than 18 years
• Pregnant
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• Illinois Retina Associates: lead

Study Sites (1)

Illinois Retina Associates

Joliet, Illinois, 60435, United States

Location

MeSH Terms

Conditions

Pain

Interventions

proxymetacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John S. Pollack, MD

  Illinois Retina Associates

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 8, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 4, 2010

Record last verified: 2009-12

Locations

US (1)