Contact Lens Adaptation in Neophytes

Study Overview
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Brief Summary
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Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.

Official Title
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Contact Lens Adaptation in Neophytes

Conditions
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Contact Lens Comfort

Intervention / Treatment
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* Device: senofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has had a completed comprehensive eye exam within the past 6 months Able to wear spherical senofilcon A contact lenses Able to use Opti-Free PureMoist contact lens solution Exclusion Criteria: Any prior contact lens use Topical eye drops within the last two hours of the study visit Known systemic health conditions known to alter tear film physiology History of severe ocular trauma Active ocular infection Active ocular inflammation Known hypersensitivity to diagnostic eye drops Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-Time Senofilcon A Contact Lens Wear<br>This group will start wearing contact lenses 8 or more hours per day on the first day of wear | Device: senofilcon A<br> <br> * Other names: Acuvue Oasys;|
| Experimental: Graduated Senofilcon A Contact Lens Wear<br>This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). | Device: senofilcon A<br> <br> * Other names: Acuvue Oasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) | This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart | The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores. | 2 weeks | 
| Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) | Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability. | 2 Weeks | 
| Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) | Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume. | 2 Weeks | 
| Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M | Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better. | 2 Weeks | 
| Between-Group Difference in Upper and Lower Eyelid Blepharitis | A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis. | 2 Weeks | 
| Between-Group Difference in Corneal Sodium Fluorescein Staining | The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining. | 2 Weeks | 
| Between-Group Difference in Tear Volume as Measured by Schirmer's Test I | Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume. | 2 Weeks | 
| Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) | End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort. | 2 Weeks | 
| Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores | Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort. | 2-Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses, Neophytes, Contact Lens Adaptation, Randomized