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.

NCT06317038 | Completed

• 1 other identifier: 89814415
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Strain

Keywords

Contact lenses; Digital Devices; Eye Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear.

  1 month

• Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.

  1 month

• Report on total daily wear time and digital device usage.

  1 month

Study Arms (1)

Digital Device uses for 8 hours per day

OTHER

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

Interventions

Total 30 Contact Lens DEVICE

Patients will be give a contact lens for 1 month

Digital Device uses for 8 hours per day

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tauber Eye Center: lead
• Alcon Research: collaborator

Study Sites (1)

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Crystal Remington OD, FAAO

Model Details: Open label Observation

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 31, 2024
• Primary Completion: November 11, 2024
• Study Completion: December 1, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)