Evaluation of Wear Experience With a Daily Disposable Contact Lens

NCT04296877 | Completed Results FDA Device

• 1 other identifier: 2020H0019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Conditions

Contact Lens

Keywords

Daily Disposable Contact Lens; Soft Contact Lens; Spherical Contact Lens

Outcome Measures

Primary Outcomes (1)

• Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey

  Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.

  2 weeks

Study Arms (1)

All study participants

EXPERIMENTAL

All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for \~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.

Device: Daily Disposable Contact Lens

Interventions

Daily Disposable Contact Lens DEVICE

Soft, daily disposable spherical contact lens used to correct distance vision.

All study participants

Eligibility Criteria

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

You may qualify if:

• Must be current Acuvue® Oasys® spherical contact lens wearers.
• 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).
• Ability to give informed consent.
• Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.
• Either gender.
• Any racial or ethnic origin.

You may not qualify if:

• No current ocular inflammation or infection.
• Not currently pregnant or lactating.

Sponsors & Collaborators

• Ohio State University: lead
• Alcon Research: collaborator

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

OPT-EyeStudies@osu.edu

16142928858

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

Model Details: This is a single arm, non-comparative study.

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 10, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)