NCT04449263

Comparing the Performance of 1 Day Multifocal Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 42 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Detailed description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Lens A	Subjects will be randomized to wear Lens A (test) for 2 weeks.
DEVICE	Lens B	Subjects will be randomized to wear Lens B (control) for 2 weeks.
DEVICE	Habitual Lenses	All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Timeline

• Start date: 2020-07-27
• Primary completion: 2020-12-07
• Completion: 2020-12-30
• First posted: 2020-06-26
• Last updated: 2021-06-22
• Results posted: 2021-06-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study