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.

Eye Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317038
• Other study ID #: 89814415
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Tauber Eye Center
• Contact: Crystal D Remington, OD
• Phone: 8165319100
• Email: drremington[@]vseyecare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Eye Strain

Intervention

Device:
• Total 30 Contact Lens
Patients will be give a contact lens for 1 month

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tauber Eye Center	Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Report on total daily wear time and digital device usage.	Survey: Total number of hours	1 month