Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Last updated: November 19, 2024
Sponsor: Jennifer Fogt
Overall Status: Completed

Phase

N/A

Condition

Presbyopia

Treatment

Daily disposable multifocal soft contact lens

Clinical Study ID

NCT06053463
2023H0245
  • Ages > 38
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 thestudy, and additional follow up visits could be scheduled if needed.

  • Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25or 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 lastmonth and the absence of medical conditions or treatments that are deemedconfounding to the data as determined by the PI

Exclusion

Exclusion Criteria:

  • Current or active ocular inflammation or infection as determined by theInvestigator.

  • Astigmatism ≥ 1.00 D in either eye.

  • History of previous eye surgery.

  • Strabismus or binocular vision abnormalities that prevent completion of testing, atthe discretion of the Investigator.

  • Demonstration or history of corneal ectasia or keratoconus.

  • Pregnant or lactating

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Daily disposable multifocal soft contact lens
Phase:
Study Start date:
October 06, 2023
Estimated Completion Date:
May 23, 2024

Study 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.

Connect with a study center

  • The Ohio State University College of Optometry

    Columbus, Ohio 43210
    United States

    Site Not Available

  • ProCare Vision Center

    Granville, Ohio 43023
    United States

    Site Not Available

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