Skip to main content
OpenTrials
Completed

NCT Number: NCT03544216

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multifocal Contact Lens

Device

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

Single vision Contact lens

Device

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

Primary outcomes

  1. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score

    Time frame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)

    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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.