NCT04535310

Brief Summary

This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

August 20, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

August 20, 2020

Results QC Date

October 13, 2022

Last Update Submit

February 3, 2023

Conditions

Keywords

Daily Disposable Contact LensSpherical Contact LensSoft Contact Lens

Outcome Measures

Primary Outcomes (1)

  • Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)

    Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.

    Up to 14 days

Study Arms (1)

Daily Disposable Contact Lens

EXPERIMENTAL

All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.

Device: Precision1® Daily Disposable Contact Lens

Interventions

Soft, spherical contact lens used to correct distance vision.

Daily Disposable Contact Lens

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be a current spherical contact lens wearer with longs days of lens wear.
  • Distance visual acuity of 20/25 or better with current contact lenses.
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
  • Recent eye exam within the past year.
  • Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
  • Ability to give informed consent.
  • Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

You may not qualify if:

  • No current ocular inflammation or infection as assessed by the study investigator.

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

Results Point of Contact

Title
Jennifer Fogt
Organization
The Ohio State University College of Optometry

Study Officials

  • Jennifer Fogt, OD, MS

    The Ohio State University College of Optometry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Clinical

Study Record Dates

First Submitted

August 20, 2020

First Posted

September 1, 2020

Study Start

October 13, 2020

Primary Completion

December 8, 2020

Study Completion

March 31, 2021

Last Updated

February 8, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations