N/A
N=60
Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear
Contact Lens-induced Corneal Fluorescein Staining
Bottom Line
View on ClinicalTrials.gov: NCT01015768 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. — 0.0567; 0.0583 nanometers per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReNu Multiplus multipurpose disinfecting solution (Device); Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. |
0.0567; 0.0583 | — |
| PRIMARY Permeability Rate, nm/Sec |
0.057; 0.058 | — |
| SECONDARY 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. |
4.95; 4.52 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01015768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.