Accommodative Relief for Uncomfortable Non-Presbyopes

Asthenopia Clinical Trial

Official title:

Accommodative Relief for Uncomfortable Non-Presbyopes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544216
• Other study ID #: 2016H0382-60058303
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: May 6, 2018

Study information

• Verified date: January 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 6, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthenopia

Intervention

Device:
• Multifocal Contact Lens
The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
• Single Vision Contact Lens
The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort.; Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms	Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)