NCT00198549

Brief Summary

The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_4 pain

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, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

September 13, 2005

Last Update Submit

March 15, 2013

Conditions

Pain

Keywords

Adjuvants, Anesthesiahyaluronate lyase

Outcome Measures

Primary Outcomes (1)

  • To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures

Secondary Outcomes (1)

  • To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial

Interventions

Vitrase (ovine hyaluronidase) LyophilizedDRUG

Eligibility Criteria

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

You may qualify if:

  • Scheduled for an ophthalmic surgical procedure

You may not qualify if:

  • Known allergy to bee venom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Chondroitinases and Chondroitin Lyases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Study Officials

  • Lisa R Grillone, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2004

Primary Completion

January 1, 2005

Study Completion

March 1, 2005

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(1)