Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

J

Jennifer Fogt

Status

Enrolling

Conditions

Presbyopia

Treatments

Device: Daily disposable multifocal soft contact lens

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06053463
2023H0245

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

38+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Lens wear experience
Experimental group
Description:
Subject will wear contact lenses for about a month during the day.
Treatment:
Device: Daily disposable multifocal soft contact lens

Trial contacts and locations

2

Loading...

Central trial contact

Emma M Ollis, BS; Jennifer Fogt, OD, MS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems