NCT03544216

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

January 12, 2017

Results QC Date

December 28, 2018

Last Update Submit

January 24, 2019

Conditions

Asthenopia

Keywords

Contact LensMultifocalAccommodationPresbyopia

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Single Vision First

EXPERIMENTAL

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 LensDevice: Single Vision Contact Lens

Multifocal first

EXPERIMENTAL

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 LensDevice: Single Vision Contact Lens

Interventions

Multifocal Contact LensDEVICE

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

Multifocal firstSingle Vision First
Single Vision Contact LensDEVICE

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

Multifocal firstSingle Vision First

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Visual acuity of 20/25 or better in both eyes with habitual contact lenses
  • D or more myopic in both eyes
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

AsthenopiaPresbyopia

Condition Hierarchy (Ancestors)

Eye DiseasesRefractive Errors

Results Point of Contact

Title
Erin Rueff, OD, PhD
Organization
Marshall B. Ketchum University (The Ohio State University during study data collection)
em.rueff@gmail.com
7654145644

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Optometrist and PhD Candidate

Study Record Dates

First Submitted

January 12, 2017

First Posted

June 1, 2018

Study Start

February 2, 2017

Primary Completion

May 6, 2018

Study Completion

May 6, 2018

Last Updated

February 15, 2019

Results First Posted

February 15, 2019

Record last verified: 2019-01

Locations

US(1)