Accommodative Relief for Uncomfortable Non-Presbyopes

NCT ID: NCT03544216

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2018-05-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single Vision First

Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions.

Group Type: EXPERIMENTAL

Multifocal Contact Lens

Intervention Type: DEVICE

The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks

Single Vision Contact Lens

Intervention Type: DEVICE

The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Multifocal first

Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions.

Group Type: EXPERIMENTAL

Multifocal Contact Lens

Intervention Type: DEVICE

The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks

Single Vision Contact Lens

Intervention Type: DEVICE

The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Interventions

Multifocal Contact Lens

The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks

Intervention Type: DEVICE

Single Vision Contact Lens

The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Visual acuity of 20/25 or better in both eyes with habitual contact lenses
• -0.75 D or more myopic in both eyes
• -0.75 D or less astigmatism in both eyes
• Current single vision contact lens wearer who does not require a reading aid
• CLDEQ-8 score of 12 or more points with habitual contact lenses
• No history of ocular surgery or medication
• Reports digital device use of at least 3 hours per day
• No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
• No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Erin Rueff

Clinical Research Optometrist and PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University College of Optometry

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016H0382-60058303

Identifier Type: -

Identifier Source: org_study_id