Longitudinal Evaluation of Silicone Hydrogel (LASH) Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study|
- Cumulative Incidence of Corneal Inflammatory Events [ Time Frame: annual ] [ Designated as safety issue: No ]Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.
Biospecimen Retention: Samples Without DNA
tear samples contact lenses bacteria isolated from contact lenses
|Study Start Date:||October 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
healthy patients fit into lotrafilcon A contact lenses for continuous wear
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Loretta B Szczotka-Flynn, OD, MS||Case Western Reserve University|