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OpenTrials
Completed

NCT Number: NCT05056987

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

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.

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Key information

Conditions

Refractive Errors Eye Diseases Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, M13 9PL, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lehfilcon A contact lenses

Device

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

Other names: TOTAL30®

Senofilcon A contact lenses

Device

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

Other names: ACUVUE OASYS® with HYDRACLEAR® Plus, AOHP

AOSEPT PLUS with HydraGlyde

Device

Hydrogen peroxide-based cleaning and disinfecting solution

Other names: AOSEPT® PLUS with HYDRAGLYDE®

Primary outcomes

  1. Distance VA (logMAR) With Study Lenses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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