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Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear

This study has been completed.
Sponsor:
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT01015768
First received: November 16, 2009
Last updated: September 8, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to assess corneal staining and to measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact lens and multipurpose lens care solution combination.


Condition Intervention Phase
Corneal Staining
 Device: ReNu Multiplus multipurpose disinfecting solution
Device: Control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:
  • The primary outcome measure will be the Pdc, the corneal epithelial permeability in nanometers per second, for the test and control eyes. [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure will be the corneal staining grade, compared between the test and control eye, as well as between the baseline and final staining for each eye. [ Time Frame: One day ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test eye
Uses ReNu Multiplus as multipurpose soaking solution
 Device: ReNu Multiplus multipurpose disinfecting solution
New lenses (PureVision) soaked 6 hours to overnight in ReNu Multiplus
Active Comparator: Control
A new lens (PureVision) is soaked for 2 hours in non-preserved saline
 Device: Control
A new lens (PureVision) is soaked for two hours in non-preserved saline

Detailed Description:

This investigation will evaluate corneal staining and epithelial barrier function after eight hours of contact lens wear, which is past the peak staining time and more typical of daily lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be used to evaluate potential corneal compromise. The study will be a prospective, single-center, double-masked, contralateral, daily wear investigation in adapted soft contact lens wearers. After a three day washout period (without lens wear, lenses will then be worn on one day for eight hours. Corneal staining and barrier function will be determined for a regimen and a saline control situation for each subject. Staining will be graded using the Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration rate, Pdc in nm/sec for the test and control condition.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
  • Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
  • Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
  • Best correctable visual acuity of at least 20/40 in each eye.
  • Willing to de-adapt (do not wear) from habitual contact lenses for a period of at least two days prior to eligibility visit and at least two days prior to the testing day.
  • Possess a functional spectacle (eyeglass) prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
  • No known allergies, which may interfere with contact lens wear.
  • No known systemic (pertaining to general health) disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).

Exclusion Criteria:

  • Less than one month successful, full time (defined as at least 8 hours per day, and more than 5 days per week) soft lens wear.
  • Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
  • Any active ocular infection.
  • Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
  • Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
  • Are taking part in any other study or have taken part in a study within the last 14 days
  • Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
  • Are pregnant, or anticipate becoming pregnant during the course of this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015768

Locations
United States, California
Southern California Colege of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Investigators
Study Director: Jerry R Paugh, OD, PhD Southern California College of Optometry
  More Information

No publications provided

Responsible Party: Jerry R. Paugh, OD, PhD, Southern California College of Optometry
ClinicalTrials.gov Identifier: NCT01015768     History of Changes
Other Study ID Numbers: 08-10
Study First Received: November 16, 2009
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:
corneal staining
barrier function
contact lenses
contact lens care solutions
contact lens material and care solution bioincompatibility

ClinicalTrials.gov processed this record on May 23, 2013