T30 for Astigmatism in Digital Device Users

NCT06266728 | Completed FDA Device

• 1 other identifier: IRB00006733
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.

Conditions

Contact Lens Complication; Astigmatism; Refractive Errors

Keywords

Total30 for astigmatism; Comfort; Dryness; Visual Analog Scale; Contact Lens

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Comfort Scores

  Participants will receive text message surveys on which they will record the comfort of their lenses throughout various points in the day, during different periods of the 1 month study. Scores will be recorded on a scale +/- 50 with +50 being the highest level of comfort and -50 being uncomfortable.

  Baseline to 1 month of Contact lens wear

Study Arms (1)

Total 30 for astigmatism contact lenses

EXPERIMENTAL

Total30 for Astigmatism Monthly Replacement Contact Lenses

Device: Total30 for Astigmatism Contact Lenses

Interventions

Total30 for Astigmatism Contact Lenses DEVICE

Participants must be refit into Total30 for Astigmatism Contact Lenses and wear them over the course of this one month study.

Also known as: Lehfilcon A

Total 30 for astigmatism contact lenses

Eligibility Criteria

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

You may qualify if:

• Adult (18- to 40-year-old)
• LogMAR visual acuity or better in their habitual CLs or by manifest refraction in both eyes
• Smart phone with text messaging capabilities
• Existing wearers of soft, frequent replacement toric CLs within past 6 months
• Frequent digital device user (e.g., phone, iPad, computer, social media, video streaming, etc.) defined as at least 8 hours of usage per day
• Willing to follow the required wear schedule
• Astigmatism ranging from 0.75 D to 2.50 D in each eye
• Willing to wear their CLs at least 13 hours/day

You may not qualify if:

• Have a known history of being diagnosed with dry eye disease
• Have a history of ocular surgery within the past 12 months
• Have a history of severe ocular trauma, active ocular infection or inflammation
• Have a history of viral eye disease
• Currently using isotretinoin-derivatives or ocular medications
• Currently using a dry eye treatment including but not limited to artificial tears
• Currently using rewetting drops daily or occasionally
• If they are pregnant or breast feeding
• Need for spectacle add power of any amount (presbyopic)
• Currently wearing T30fA CLs
• Have a history of wearing hard CLs
• Subjects who show excessive lens oscillation with the T30fA lenses during the fitting process yet show 0.0 logMAR acuity, will be excluded from the study.
• Patients who report unstable vision while wearing their habitual or study CLs (e.g., rotational instability of CLs)
• Willing to not use any artificial tears or dry eye treatments during the study
• Willing to not use rewetting drops during the study

Sponsors & Collaborators

• Southern College of Optometry: lead
• Alcon Research: collaborator

Study Sites (2)

Kannar Eye Care

Pittsburg, Kansas, 66762, United States

Location

Coldwater VIsion Center

Coldwater, Mississippi, 38618, United States

Location

MeSH Terms

Conditions

Astigmatism; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism contact lenses.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 18, 2024
• Last Updated: February 24, 2025

Record last verified: 2024-04

Locations

US (2)