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Daily Wear Corneal Infiltrative Event Study

NCT00937105 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2014-03-10

Study results available
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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.

Conditions

  • Myopia
  • Hyperopia
  • Corneal Infiltrative Events

Interventions

DEVICE

lotrafilcon A contact lenses

FDA approved soft contact lenses

DEVICE

Renu Multiplus

DEVICE

Clear Care

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Loretta Szczotka-Flynn, OD, PhD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937105 on ClinicalTrials.gov