Total30 For Contact Lens Dropouts

NCT ID: NCT06967298

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2024-11-28

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."

Detailed Description

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."1 While CL dropout occurs in about 20% of wearers annually the majority of CL wearers who cease wearing their CLs have a desire to continue wearing their CL if given the opportunity.3 A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs Therefore, providing CL dropouts with an alternative material, which may be more comfortable than their past CLs, could be a means for curbing CL dropout.

Our recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into Dailies TOTAL1® CLs that 100% of them were still wearing Dailies TOTAL1® at 1 month and 98% of them were still wearing their CLs at 6 months. When these participants were asked at the 1-month visit, 98.3%, 86.5%, and 93.2% of them responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort, and overall CL comfort, respectively. These same participants responded at 6 months that they were very likely or likely to continue to wear the study CLs (80.7%) and to recommend the study CLs to a friend (93.2%). While these data suggest that CL dropout can thrive when being refit into a daily disposable CLs, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. One good potential monthly CL option is the TOTAL30® (T30) CL. T30 is a relatively new frequent replacement CL, with a biocompatible design. Thus, the purpose of this study is to determine the frequency that CL dropouts who dropped out of CLs because of dryness or discomfort can be comfortably refit into T30 CLs at 1 month.

Conditions

Dry Eye; Contact Lens Complication; Contact Lenses

Study Design

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

Study Groups

T30 For Dropouts

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

Group Type: EXPERIMENTAL

T30 Contact lenses

Intervention Type: 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.

Interventions

T30 Contact lenses

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Southern College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Southern College of Optometry

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

irb00006763

Identifier Type: -

Identifier Source: org_study_id