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

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: AOSEPT PLUS with HydraGlyde; Device: Senofilcon A contact lenses; Device: Lehfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056987

CLY935-C018

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

TOTAL30, then AOHP

Other group

Description:

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.

Treatment:

Device: Lehfilcon A contact lenses

Device: Senofilcon A contact lenses

Device: AOSEPT PLUS with HydraGlyde

AOHP, then TOTAL30

Other group

Description:

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.

Treatment:

Device: Lehfilcon A contact lenses

Device: Senofilcon A contact lenses

Device: AOSEPT PLUS with HydraGlyde