Wear Experience With Daily Toric Contact Lenses Over a Long Day

November 8, 2023 updated by: Jennifer Fogt, Ohio State University

Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
  • Distance visual acuity of 20/25 or better with current lenses.
  • Recent eye exam in the last year.
  • 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).
  • Ability to give informed consent.
  • Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
  • Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Exclusion Criteria:

  • Current ocular inflammation or infection as assessed by the study investigator.
  • Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily Disposable Toric Contact Lens
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Device: Precision1® Daily Disposable Toric Contact Lens
Soft, toric contact lens used to correct distance vision and astigmatism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
Time Frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
1 describes poor experience, and 10 describes excellent experience.
Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
Time Frame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days
1 describes poor experience, and 10 describes excellent experience.
Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Actual)

August 24, 2021

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020H0559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contact Lens

Clinical Trials on Precision1® Daily Disposable Toric Contact Lens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe