Wear Experience With Daily Toric Contact Lenses Over a Long Day

NCT04844281 | Completed Results FDA Device

• 1 other identifier: 2020H0559
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Lens; Astigmatism of Both Eyes

Keywords

Toric Contact Lens; Daily Contact Lens

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

Study Arms (1)

Daily Disposable Toric Contact Lens

EXPERIMENTAL

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

Interventions

Precision1® Daily Disposable Toric Contact Lens DEVICE

Soft, toric contact lens used to correct distance vision and astigmatism.

Daily Disposable Toric Contact Lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Alcon Research: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Results Point of Contact

• Title: Jennifer Fogt, OD MS
• Organization: The Ohio State University College of Optometry

OPTEyeStudies@osu.edu

16142928858

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 of Clinical Optometry

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: May 11, 2021
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)