Total30 for Astigmatism Contact Lenses

NCT06052046 | Completed FDA Device

• 1 other identifier: IRB-00006733
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

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

  A VAS will be used to compare end of day ocular comfort at about 16 hours of contact lens wear (± 50 scale with +50 being best possible comfort and -50 being worst possible comfort).

  Change from baseline at 1 month

Study Arms (1)

Total30 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 will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.

Also known as: Lehfilcon A

Total30 for Astigmatism Contact Lenses

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45-year-old
• Visual acuity 20/20 or better
• Contact Lens Dry Eye Questionnaire \[CLDEQ\]-8 scores \<10
• Willing to wear Total30 for Astigmatism CLs
• Have a smart phone with text messaging capabilities
• Astigmatism ranging from 0.75 D to 2.50 D in each eye
• Regularly worn 2 week or monthly CLs within the past 6 months
• Current CL wearer
• Glasses prescription that is less than 2 years old
• Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected

You may not qualify if:

• Current or past hard CL wearers
• A known systemic health condition that is thought to alter tear film physiology
• A history of viral eye disease
• A history of ocular surgery
• A history of severe ocular trauma
• Have an active ocular infection or inflammation
• Currently using isotretinoin-derivatives or ocular medications
• Currently using rewetting drops or artificial tears
• Pregnant or breast feeding
• Willing to discontinue usage of current toric CLs one week prior to the initial visit

Sponsors & Collaborators

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

Study Sites (2)

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Coldwater VIsion Center

Coldwater, Mississippi, 38618, United States

Location

Related Publications (1)

• Lievens C, Perkins A, Rayborn E, Wang Y, Franklin Q, May K, Kannarr S, Bromley M, Pucker AD. Real-Time Changes in the Comfort of a Toric, Monthly, Soft Contact Lens Over a Long Day of Wear. Clin Optom (Auckl). 2024 Dec 17;16:317-325. doi: 10.2147/OPTO.S490934. eCollection 2024.

  PMID: 39713278 DERIVED

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: September 18, 2023
• First Posted: September 25, 2023
• Study Start: October 15, 2023
• Primary Completion: May 11, 2024
• Study Completion: June 1, 2024
• Last Updated: February 24, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)