Clinical trial NCT02148263: Contact Lens Adaptation in Neophytes
Official title: Contact Lens Adaptation in Neophytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Comfort
Keywords: Contact Lenses
Neophytes
Contact Lens Adaptation
Randomized
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2014-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
timeFrame: 2 weeks
Secondary outcomes:
measure: Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
timeFrame: 2 weeks
measure: Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
timeFrame: 2 Weeks
measure: Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
timeFrame: 2 Weeks
measure: Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
timeFrame: 2 Weeks
measure: Between-Group Difference in Upper and Lower Eyelid Blepharitis
timeFrame: 2 Weeks
measure: Between-Group Difference in Corneal Sodium Fluorescein Staining
timeFrame: 2 Weeks
measure: Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
timeFrame: 2 Weeks
measure: Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
timeFrame: 2 Weeks
measure: Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
timeFrame: 2-Weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Andrew D Pucker, OD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Jeffrey J Walline, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
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citation: Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010.
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citation: Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.