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NCT00937105 · ClinicalTrials.gov registry record · Phase 4
Daily Wear Corneal Infiltrative Event Study
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 218
- Enrollment target
NCT00937105 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 218 participants.
The verdict
NCT00937105, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 218 participants
- Enrollment target
Study Summary
This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.
Interventions
- DEVICE Clear Care
- DEVICE lotrafilcon A contact lenses
- DEVICE Renu Multiplus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00937105
The ClinicalTrials.gov registry entry for NCT00937105 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Clear Care is the first listed.
NCT00937105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00937105 about?
NCT00937105 is a clinical study titled "Daily Wear Corneal Infiltrative Event Study". This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or ...
What is the current status of trial NCT00937105?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 218 participants. The study started on 2009-11. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00937105?
The interventions under investigation include: Clear Care (DEVICE), lotrafilcon A contact lenses (DEVICE), Renu Multiplus (DEVICE).
Who is sponsoring clinical trial NCT00937105?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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