Contact Lens Adaptation in Neophytes

Not Applicable

Completed

Conditions: Contact Lens Comfort

Interventions: Device: senofilcon A

Registration Number: NCT02148263

Lead Sponsor: Ohio State University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graduated Senofilcon A Contact Lens Wear	senofilcon A	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).
Full-Time Senofilcon A Contact Lens Wear	senofilcon A	This group will start wearing contact lenses 8 or more hours per day on the first day of wear

Primary Outcome Measures

Name	Time	Method
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores	2-Weeks	Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort.
Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)	2 Weeks	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.
Between-Group Difference in Tear Volume as Measured by Schirmer's Test I	2 Weeks	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.
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart	2 weeks	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.
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M	2 Weeks	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.
Between-Group Difference in Corneal Sodium Fluorescein Staining	2 Weeks	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.
Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)	2 Weeks	End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.
Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)	2 Weeks	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.
Between-Group Difference in Upper and Lower Eyelid Blepharitis	2 Weeks	A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.