NCT06053463

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Jennifer Fogt · Academic / Other
• Sex: All
• Age: 38 Years
• Healthy volunteers: Accepted

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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Daily disposable multifocal soft contact lens	Daily disposable multifocal soft contact lens that will be worn for 1 month.

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2023-09-25
• Last updated: 2024-11-27
• Results posted: 2024-11-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study