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NCT00198419 · ClinicalTrials.gov registry record · Phase 1
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
A Phase 1 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00198419: Completed Phase 1 study, sponsored by Bausch & Lomb Incorporated.
NCT00198419 is a Phase 1 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00198419, a Phase 1 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.
Primary Outcome
hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase
Interventions
- DRUG Vitrase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00198419 record still lists
NCT00198419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Vitrase is the first listed.
NCT00198419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00198419 about?
NCT00198419 is a clinical study titled "Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)". The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.
What is the current status of trial NCT00198419?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2004-03. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00198419?
The interventions under investigation include: Vitrase (DRUG).
Who is sponsoring clinical trial NCT00198419?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00198419's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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