NCT04952701

Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 42 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Detailed description

This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Control lenses	Control Multifocal lenses
DEVICE	Test lenses	Test Multifocal lenses

Timeline

• Start date: 2021-10-21
• Primary completion: 2021-12-01
• Completion: 2022-01-14
• First posted: 2021-07-07
• Last updated: 2022-04-27
• Results posted: 2022-04-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study