NCT06967298

Total30 For Contact Lens Dropouts

How Does Total 30 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Southern College of Optometry · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-04-23
• Primary completion: 2024-11-20
• Completion: 2024-11-28
• First posted: 2025-05-13
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study