To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.

Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415

To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.

Study Overview

• Status: Completed
• Conditions: Eye Strain
• Intervention / Treatment: Device: Total 30 Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients aged 18-40 of any sex and any race.
• Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
• Wearing contact lenses for at least 13 hours daily 5 days per week.
• Spherical refractive error between -11.00 D and +6.00D with < -0.75 D of astigmatism.
• Willing to comply with the protocol instructions.
• Has read (or has had read to), understood, and signed an Informed Consent.
• Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion Criteria:

• Active ocular infection or ocular inflammatory disease.
• Presbyopic or pre-presbyopic that have a measured add power for reading.
• Current Total 30 contact lens wearer.
• Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
• Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
• History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
• Participation by the patient in any other investigational study within the past 30 days.
• Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
• Inability to utilize Clear Care Cleaning solution.
• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Digital Device uses for 8 hours per day; Observational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens.	Device: Total 30 Contact Lens; Patients will be give a contact lens for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).	Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear.	Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree	1 month
Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.	VAS diary: scale 0-100 (0=No Discomfort 100= Maximal Comfort)	1 month
Report on total daily wear time and digital device usage.	Survey: Total number of hours	1 month

Collaborators and Investigators

• Sponsor: Tauber Eye Center
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2024
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Contact lenses; Eye Comfort; Digital Devices
• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID Numbers: 89814415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No