Accommodative Relief for Uncomfortable Non-Presbyopes

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).

Study Overview

• Status: Completed
• Conditions: Asthenopia
• Intervention / Treatment: Device: Multifocal Contact Lens; Device: Single Vision Contact Lens

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): May 6, 2018
• Study Completion (Actual): May 6, 2018

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Presbyopia; Accommodation; Contact Lens; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID Numbers: 2016H0382-60058303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No