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

Alcon Research36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractive Errors

Interventions

Lehfilcon A contact lensesDEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

Senofilcon A contact lensesDEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

AOSEPT PLUS with HydraGlydeDEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eurolens Research

Manchester, United Kingdom

Outcomes

Primary Outcomes

Distance VA (logMAR) With Study Lenses

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.

Time frame: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)

Data from ClinicalTrials.gov

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