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Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers

Not Applicable
Active, not recruiting
Conditions
Myopia
Interventions
Device: Biweekly replacement contact lenses
Device: One week replacement contact lenses
Registration Number
NCT06382064
Lead Sponsor
Ohio State University
Brief Summary

This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
71
Inclusion Criteria
  1. At least 18 years of age
  2. Ability to give informed consent
  3. Current Acuvue® Oasys® spherical lens wearer.
  4. Distance visual acuity of 20/25 or better with current contact lenses in each eye.
  5. Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
  6. Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.
Exclusion Criteria
  1. Current or active ocular inflammation or infection as determined by the Investigator.
  2. Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
  3. Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Contact Lens Wear ExperienceOne week replacement contact lensesParticipants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks.
Contact Lens Wear ExperienceBiweekly replacement contact lensesParticipants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks.
Primary Outcome Measures
NameTimeMethod
Subjective Assessment of Lens Wear ExperienceAfter 2 weeks of wear in the 1-week replacement reusable lenses.

Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Ohio State University College of Optometry

🇺🇸

Columbus, Ohio, United States

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