Evaluation of Vitrase as a Spreading Agent

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Vitrase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198484

ISTA-VIT-SA-CS06

Details and patient eligibility

About

The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for an ophthalmic surgical procedure

Exclusion criteria

• Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase
• Known history of hypersensitivity reaction to bee or wasp venom
• Needing enhanced absorption and dispersion of dopamine, alpha agonist drugs, furosemide, the benzodiazepines, or phenytoin
• Inflammation or apparent clinical signs of infection in the area where Vitrase was to be injected

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Vitrase

Experimental group

Description:

ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery

Treatment:

Drug: Vitrase