NCT03653715

Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Clerio Vision, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.

Detailed description

Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by researchers at the University of Rochester known as Laser Induced Refractive Index Customization (LIRIC), which allows the alteration of the optical design of a finished soft hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal optical design using the LIRIC procedure which shows an increase of the depth of focus of the contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient wearing a soft contact lens of this design will experience an improvement in intermediate and near vision over that provided by their distance corrected single vision contact lenses, without significantly impacting their distance vision. The purpose of this feasibility study is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified soft contact lenses. Results from this study will guide future development of these potential products.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Clerio Vision LIRIC-modified Bifocal Contact Lens	Within this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
DEVICE	Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens	Within this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
DEVICE	Johnson & Johnson 1-Day Acuvue Moist Contact Lens	Within this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
DEVICE	Clerio Vision Single Vision Contact Lens	Within this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Timeline

• Start date: 2018-08-06
• Primary completion: 2018-08-27
• Completion: 2018-10-12
• First posted: 2018-08-31
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study