Wear Experience With Daily Contact Lenses Over a Long Day

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04535310
• Collaborator: Alcon Research (Industry)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contact Lens	Device: Precision1® Daily Disposable Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
• Actual Study Start Date: Oct 13, 2020
• Actual Primary Completion Date: Dec 8, 2020
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daily Disposable Contact Lens 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; Soft, spherical contact lens used to correct distance vision.

Outcome Measures

Primary Outcome Measures

1. Subjective comfort and vision as assessed using the Visual Analog Scale (VAS) [Up to 14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Alcon Research

Investigators

• Principal Investigator: Jennifer Fogt, OD, MS, The Ohio State University College of Optometry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Fogt, Associate Professor Clinical, Ohio State University
• ClinicalTrials.gov Identifier: NCT04535310
• Other Study ID Numbers: 2020H0324
• First Posted: Sep 1, 2020
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Jennifer Fogt, Associate Professor Clinical, Ohio State University: Daily Disposable Contact Lens; Spherical Contact Lens; Soft Contact Lens

Study Results

No Results Posted as of Apr 13, 2021