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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

Tracking Information
First Submitted Date  ICMJE January 12, 2017
First Posted Date  ICMJE June 1, 2018
Results First Submitted Date  ICMJE December 28, 2018
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE February 2, 2017
Actual Primary Completion Date May 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score [ Time Frame: Completed after 2 weeks of contact lens wear ]
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.
Change History Complete list of historical versions of study NCT03544216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accommodative Relief for Uncomfortable Non-Presbyopes
Official Title  ICMJE Accommodative Relief for Uncomfortable Non-Presbyopes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Asthenopia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Multifocal Contact Lens
    • Device: Single Vision Contact Lens
  • 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.
    Interventions:
    • Device: Multifocal Contact Lens
    • Device: Single Vision Contact Lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2018)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 6, 2018
Actual Primary Completion Date May 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03544216
Other Study ID Numbers  ICMJE 2016H0382-60058303
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin Rueff, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Bausch & Lomb Incorporated
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP