NCT03705130

Brief Summary

This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 14, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

June 14, 2018

Last Update Submit

October 11, 2018

Conditions

Keywords

Multifocal Contact LensMyopiaVisual Performance

Outcome Measures

Primary Outcomes (1)

  • Low Contrast Visual Acuity with Glare

    Vision with contact lenses measured under low illumination conditions with glare source

    Through study completion, an average of 3 hours

Secondary Outcomes (1)

  • Low Contrast Visual Acuity without Glare

    Through study completion, an average of 3 hours

Study Arms (1)

Group 1

All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2.

Device: Single Vision Contact LensDevice: Multifocal Contact Lens 1Device: Multifocal Contact Lens 2

Interventions

Spherical Contact Lens worn on non-dispensing basis

Also known as: comfilcon A
Group 1

Multifocal Contact Lens worn on non-dispensing basis

Also known as: comfilcon A
Group 1

Multifocal Contact Lens worn on non-dispensing basis

Also known as: etafilcon A
Group 1

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects between the ages of 18-39 (inclusive) without significant ocular disease.

You may qualify if:

  • to 39 years of age
  • Best corrected visual acuity of at least 20/30
  • Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane

You may not qualify if:

  • Greater than -1.00 diopter of refractive astigmatism at the corneal plane
  • Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
  • History of ocular trauma or surgery causing abnormal or distorted vision
  • Current Rigid Gas Permeable (RGP) contact lens wearers
  • Unwilling to have eyes photographed or video recorded
  • Pregnant and/or lactating females, by self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (1)

  • Nti AN, Gregory HR, Ritchey ER, Wolffsohn JS, Berntsen DA. Contrast Sensitivity with Center-distance Multifocal Soft Contact Lenses. Optom Vis Sci. 2022 Apr 1;99(4):342-349. doi: 10.1097/OPX.0000000000001874.

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 14, 2018

First Posted

October 15, 2018

Study Start

June 14, 2018

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations