Total30 For Contact Lens Dropouts

NCT06967298 | Completed FDA Device

• 1 other identifier: irb00006763
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear."

Conditions

Dry Eye; Contact Lens Complication; Contact Lenses

Outcome Measures

Primary Outcomes (2)

• Likelihood of continuing to wear T30 CLs at 1 month and 6 months

  Participants will be refit into new contact lenses and their comfort will be asked about their comfort.In which a higher score is better.

  1 month and 6 months

• Overall satisfaction while wearing T30 CLs at 1 month and 6 months.

  Comfort in the lenses will be judged at 1 and 6 months to determine if the participant is satisfied using Visual Acuity scores in which higher scores are better.

  1-6 months

Study Arms (1)

T30 For Dropouts

EXPERIMENTAL

Total 30 contact lenses for those who have previously dropped out of CL wear

Device: T30 Contact lenses

Interventions

T30 Contact lenses DEVICE

Individuals who have previously dropped out of Contact lenses (CL) due to discomfort will be refit into T30 contact lenses and their comfort with the product will be assessed.

T30 For Dropouts

Eligibility Criteria

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

You may qualify if:

• Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
• Participants will be required to have worn reusable CLs for at least one year in the past.
• Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
• Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
• This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
• a. Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.
• Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
• Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
• Participants will be required to provide a prescription for glasses that is less than 3 years old.

You may not qualify if:

• if they are past rigid CL wearers,
• have worn reusable CLs within the past two years,
• have a history of being diagnosed with dry eye or ocular allergies,
• have known systemic health conditions that are thought to alter tear film physiology,
• have a history of viral eye disease,
• have a history of ocular surgery,
• have a history of severe ocular trauma,
• have a history of corneal dystrophies or degenerations,
• have active ocular infection or inflammation,
• are currently using isotretinoin-derivatives or ocular medications, or
• if they are pregnant or breast feeding.

Sponsors & Collaborators

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

Study Sites (1)

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; 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 6 month 4 visit survey will refit individuals who have previously dropped out of contact lenses that is stopped wearing them due to discomfort into T30 contact lenses to determine if they are comfortable.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: May 13, 2025
• Study Start: April 23, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 28, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)