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Longitudinal Evaluation of Silicone Hydrogel (LASH) Study

NCT00727402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2012-02-15

Study results available
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Summary

The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH) contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted patients with minimal or no astigmatism and no contraindications to CW lens use will be followed for 1 year. The primary outcome measure is the time to development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is corneal staining. Other key exploratory variables include bacterial contamination of study lenses and inflammatory mediators found in the tear film.

Conditions

  • Corneal Infiltrates

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Loretta B Szczotka-Flynn, OD, MS · Case Western Reserve University

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-01-31
Completion
2009-10-31

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 NCT00727402 on ClinicalTrials.gov