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.

NCT ID: NCT06317038

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Total 30 Contact Lens

Intervention Type: DEVICE

Patients will be give a contact lens for 1 month

Interventions

Total 30 Contact Lens

Patients will be give a contact lens for 1 month

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Tauber Eye Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Tauber

Crystal Remington OD, FAAO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tauber Eye Center

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

89814415

Identifier Type: -

Identifier Source: org_study_id