Contact Lens Adaptation in Neophytes (CLAN)
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|ClinicalTrials.gov Identifier: NCT02148263|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contact Lens Comfort||Device: senofilcon A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Contact Lens Adaptation in Neophytes|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 20, 2019|
|Actual Study Completion Date :||September 3, 2019|
Experimental: Full-Time Senofilcon A Contact Lens Wear
This group will start wearing contact lenses 8 or more hours per day on the first day of wear
Device: senofilcon A
Other Name: Acuvue Oasys
Experimental: Graduated Senofilcon A Contact Lens Wear
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
Other Name: Acuvue Oasys
- Ocular Surface Disease Index [ Time Frame: Change from Baseline at 2 weeks ]This is an eye comfort survey.
- Visual Acuity [ Time Frame: Change from Baseline at 2 weeks ]The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. If the patient is unable to read the 20/40 letters, the investigator will pinhole over the subject's unaided or presenting refractive error correction (glasses) to determine the subject's visual potential. The investigator will encourage the subject to do their best while reading the chart.
- Non-Invasive Break Up Time (NIBUT) [ Time Frame: Change from Baseline at 2 weeks ]A Medmont E300, which is a device used during routine eye exams, will be used to determine the subject's NIBUT.7 In brief, the Medmont will be positioned over the subject's right eye. The subject will then be asked to look into the instrument at the central green ring. They will then be asked to blink three times. After the third blink, the subject will be asked to keep their eyes open and to not blink for as long as possible while the investigator records NIBUT as the amount of time required for the first distortion detected in the array of Placido disk rings. The subject will then be allowed to blink normally for ten seconds before repeating the procedure on the fellow eye. NIBUT will be repeated in triplicate for each eye and averaged.
- Tear Meniscus Height [ Time Frame: Change from Baseline at 2 weeks ]The Oculus Keratograph 5M will be used to determine the subject's tear meniscus height. In brief, the subject will be asked to look at the target within the instrument. The subject will then be asked to blink at a normal rate and remain still until the instrument has determined their tear meniscus height.
- Bulbar & Limbal Redness [ Time Frame: Change from Baseline at 2 weeks ]The Oculus Keratograph 5M will also be used to determine the subject's bulbar and limbal redness. In brief, the subject will be asked to look at the instrument. The instrument will then automatically quantify the subject's degree of bulbar and limbal redness.
- General Slit-Lamp Exam [ Time Frame: Change from Baseline at 2 weeks ]The investigator will use a slit-lamp biomicroscope to document the general appearance of the anterior eye structures: eye lashes, eyelids, conjunctiva, and cornea. Eyelids will be graded based upon a grading scale that was agreed upon by the investigators. The front of each eye will also be evaluated to confirm that the subject's eyes are healthy.
- Corneal Staining [ Time Frame: Change from Baseline at 2 weeks ]A sterile sodium fluorescein strip will be wet with sterile saline and applied to the superior bulbar conjunctiva. After waiting for about one minute, corneal staining will be assessed with a cobalt blue light and a yellow filter. The Cornea and Contact Lens Research Unit CCLRU grading scale will be used to evaluate staining.
- Schirmer's Test I [ Time Frame: Change from Baseline at 2 weeks ]Tear volume will be assessed with Schirmer's Test. In brief, the strip will be placed at the temporal third of the lower eyelids. The subject will then be asked to close their eyes lightly for five minutes. The length of wetting will then be measured and recorded in mm.
- Visual Analog Scale [ Time Frame: Change from Baseline at 2 weeks ]All subjects will also be given an eye comfort diary to be taken home and used on a daily basis; subjects will record their end of day contact lens wear comfort in this diary on a visual analog scale (1-100 scale).They will also document their approximate contact lens wear time in this diary.
- Contact Lens Dry Eye Questionnaire (CLDEQ) [ Time Frame: Change from Baseline at 2 weeks ]This is a contact lens dry eye survey.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148263
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Andrew D Pucker, OD, MS||Ohio State University|
|Principal Investigator:||Jeffrey J Walline, OD, PhD||Ohio State University|