NCT05056987

Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

Detailed description

Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Lehfilcon A contact lenses	CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
DEVICE	Senofilcon A contact lenses	CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
DEVICE	AOSEPT PLUS with HydraGlyde	Hydrogen peroxide-based cleaning and disinfecting solution

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2021-09-27
• Last updated: 2023-06-18
• Results posted: 2023-06-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study