Longitudinal Evaluation of Silicone Hydrogel (LASH) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Loretta Szczotka-Flynn, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00727402
First received: July 31, 2008
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition
Corneal Infiltrates

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • 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


Enrollment: 205
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
healthy patients fit into lotrafilcon A contact lenses for continuous wear

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

study volunteers from academic community willing to wear extended wear contact lenses

Criteria

Inclusion Criteria:

  1. The patient must be at least 15 years old. Children younger than this may not be mature enough for CW, and may have difficulty following the strict instructions required for CW or sitting through the exam procedures.
  2. The patient must have clear central corneas and free of any anterior segment disorders.
  3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder. The parameters of the Ciba Vision Night and Day Lenses range from +6.00 to -10.00 D, and can correct the refractive range of this population. Monovision correction will be allowed only if the near eye does not exceed +6.00 D.
  4. The patient must be correctable to 20/25 or better with spectacles. Amblyopia will be excluded.
  5. Flat and steep corneal curvatures from SimK readings must be between 39.00 and 48.00 D. Corneal curvatures outside this range may be indicative of a disease state, and patients are not expected to comfortably wear either the 8.4 mm or 8.6 mm base curve available in Night and Day.(Dumbleton K 2002)
  6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria:

  1. The patient has worn rigid gas permeable lenses within the last 30 days or PMMA lenses within the last 3 months. These lenses can transiently alter the corneal shape and influence the fitting of soft lenses.
  2. The patient must not be a current extended wear user of lotrafilcon A lenses.
  3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
  4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology.
  5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  6. The patient is taking any ocular medications.
  7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to CW.
  8. The patient is pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727402

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Loretta B Szczotka-Flynn, OD, MS Case Western Reserve University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Loretta Szczotka-Flynn, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00727402     History of Changes
Other Study ID Numbers: K23 EY015270-01
Study First Received: July 31, 2008
Results First Received: November 9, 2010
Last Updated: February 13, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 22, 2014