Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Presbyopia Clinical Trial

Official title:

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053463
• Other study ID #: 2023H0245
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Emma M Ollis, BS
• Phone: 614-292-8858
• Email: OPT-EyeStudies[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Daily disposable multifocal soft contact lens
Daily disposable multifocal soft contact lens that will be worn for 1 month.

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	ProCare Vision Center	Granville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Fogt	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses	1 month
Primary	Quality of Life Survey	Assessment of the participant's quality of life with the daily disposable multifocal contact lenses	1 month