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

May 23, 2023 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9PL
        • Eurolens Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TOTAL30, then AOHP
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.
Device: Lehfilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Other Names:
  • TOTAL30®
Device: Senofilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Other Names:
  • AOHP
  • ACUVUE OASYS® with HYDRACLEAR® Plus
Device: AOSEPT PLUS with HydraGlyde
Hydrogen peroxide-based cleaning and disinfecting solution
Other Names:
  • AOSEPT® PLUS with HYDRAGLYDE®
Other: AOHP, then TOTAL30
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.
Device: Lehfilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Other Names:
  • TOTAL30®
Device: Senofilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Other Names:
  • AOHP
  • ACUVUE OASYS® with HYDRACLEAR® Plus
Device: AOSEPT PLUS with HydraGlyde
Hydrogen peroxide-based cleaning and disinfecting solution
Other Names:
  • AOSEPT® PLUS with HYDRAGLYDE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Actual)

June 14, 2022

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLY935-C018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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