MedPath

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Not Applicable
Completed
Conditions
Presbyopia
Interventions
Device: Daily disposable multifocal soft contact lens
Registration Number
NCT06053463
Lead Sponsor
Jennifer Fogt
Brief Summary

To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

Detailed Description

The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
Inclusion Criteria
  • Ability to give informed consent.
  • Any gender.
  • Any racial or ethnic origin.
  • At least 38 years of age or older.
  • Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
  • Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
  • Spectacle sphere power range between +6.00 to -10.00.
  • Previously dropped out of contact lens wear due to vision or vision and discomfort.
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI
Exclusion Criteria
  • Current or active ocular inflammation or infection as determined by the Investigator.
  • Astigmatism ≥ 1.00 D in either eye.
  • History of previous eye surgery.
  • Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
  • Demonstration or history of corneal ectasia or keratoconus.
  • Pregnant or lactating

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Lens wear experienceDaily disposable multifocal soft contact lensSubject will wear contact lenses for about a month during the day.
Primary Outcome Measures
NameTimeMethod
Visual Analog Scale1 month

Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50).

Quality of Life Survey1 month

Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

The Ohio State University College of Optometry

🇺🇸

Columbus, Ohio, United States

ProCare Vision Center

🇺🇸

Granville, Ohio, United States

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