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Accommodative Relief for Uncomfortable Non-Presbyopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544216
Recruitment Status : Completed
First Posted : June 1, 2018
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Erin Rueff, Ohio State University

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).

Condition or disease Intervention/treatment Phase
Asthenopia Device: Multifocal Contact Lens Device: Single Vision Contact Lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Accommodative Relief for Uncomfortable Non-Presbyopes
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : May 6, 2018
Actual Study Completion Date : May 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544216


Locations
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United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Bausch & Lomb Incorporated
  Study Documents (Full-Text)

Documents provided by Erin Rueff, Ohio State University:

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Responsible Party: Erin Rueff, Clinical Research Optometrist and PhD Candidate, Ohio State University
ClinicalTrials.gov Identifier: NCT03544216     History of Changes
Other Study ID Numbers: 2016H0382-60058303
First Posted: June 1, 2018    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Erin Rueff, Ohio State University:
Contact Lens
Multifocal
Accommodation
Presbyopia
Additional relevant MeSH terms:
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Asthenopia
Eye Diseases