Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

NCT05580575 | Completed Results FDA Device

• 1 other identifier: 2022H0270
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.

Conditions

Astigmatism Bilateral

Keywords

contact lenses; astigmatism

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale Survey of Overall Comfort

  Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"

  1 month

Study Arms (2)

Daily disposable lens worn first, reusable lens worn second

EXPERIMENTAL

Subject will wear each contact lenses for 30 days during the day only.

Device: Daily disposable toric soft contact lens; Device: Monthly replacement toric daily wear soft contact lens

Reusable lens worn first, daily disposable lens worn second

EXPERIMENTAL

Subject will wear each contact lenses for 30 days during the day only.

Device: Daily disposable toric soft contact lens; Device: Monthly replacement toric daily wear soft contact lens

Interventions

Daily disposable toric soft contact lens DEVICE

Daily disposable toric soft contact lens

Daily disposable lens worn first, reusable lens worn second; Reusable lens worn first, daily disposable lens worn second

Monthly replacement toric daily wear soft contact lens DEVICE

Monthly replacement toric daily wear soft contact lens

Daily disposable lens worn first, reusable lens worn second; Reusable lens worn first, daily disposable lens worn second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be current soft lens wearers in both eyes.
• Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
• 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
• Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
• Either gender
• Any racial or ethnic origin

You may not qualify if:

• Participants cannot be pregnant or lactating.
• Participants cannot be current wearers of the study lenses
• No current ocular inflammation or infection as assessed by the study investigator

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (3)

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

fogt.78@osu.edu

614-292-0882

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: PI

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: November 1, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)