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

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: AOSEPT PLUS with HydraGlyde

• Registration Number: NCT05056987
• Lead Sponsor: Alcon Research

Brief 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).

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-27
• Study Start: 2022-01-12
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14
• Status Verified: 2023-05
• Results First Submitted: 2023-05-23
• Results First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Results First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
• Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
• Willing to NOT use rewetting/lubricating drops at any time during the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
• Habitual AOHP contact lens wearers (in the past 3 months).
• Monovision wear during the study.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TOTAL30, then AOHP	AOSEPT PLUS with HydraGlyde	Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
AOHP, then TOTAL30	Lehfilcon A contact lenses	Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
TOTAL30, then AOHP	Lehfilcon A contact lenses	Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
AOHP, then TOTAL30	Senofilcon A contact lenses	Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
TOTAL30, then AOHP	Senofilcon A contact lenses	Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
AOHP, then TOTAL30	AOSEPT PLUS with HydraGlyde	Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Distance VA (logMAR) With Study Lenses	Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)	Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom