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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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Information provided by (Responsible Party):
Andrew Pucker, 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.

Condition or disease Intervention/treatment Phase
Contact Lens Comfort Device: senofilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Ocular Surface Disease Index [ Time Frame: Change from Baseline at 2 weeks ]
    This is an eye comfort survey.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Contact Lens Dry Eye Questionnaire (CLDEQ) [ Time Frame: Change from Baseline at 2 weeks ]
    This is a contact lens dry eye survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institutes of Health (NIH)
National Eye Institute (NEI)
Investigators
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Principal Investigator: Andrew D Pucker, OD, MS Ohio State University
Principal Investigator: Jeffrey J Walline, OD, PhD Ohio State University

Publications:

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Responsible Party: Andrew Pucker, Senior Research Associate, Ohio State University
ClinicalTrials.gov Identifier: NCT02148263     History of Changes
Other Study ID Numbers: 2014H0074
K08EY023264 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by Andrew Pucker, Ohio State University:
Contact Lenses
Neophytes
Contact Lens Adaptation
Randomized