NCT03544216

Accommodative Relief for Uncomfortable Non-Presbyopes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 30 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

Detailed description

The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Conditions

• Asthenopia

Interventions

Type	Name	Description
DEVICE	Multifocal Contact Lens	The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
DEVICE	Single Vision Contact Lens	The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Timeline

• Start date: 2017-02-02
• Primary completion: 2018-05-06
• Completion: 2018-05-06
• First posted: 2018-06-01
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study