NCT05056987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

September 15, 2021

Results QC Date

May 23, 2023

Last Update Submit

May 23, 2023

Conditions

Refractive Errors

Keywords

Contact LensesMyopia

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (2)

TOTAL30, then AOHP

OTHER

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 lensesDevice: Senofilcon A contact lensesDevice: AOSEPT PLUS with HydraGlyde

AOHP, then TOTAL30

OTHER

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 lensesDevice: Senofilcon A contact lensesDevice: AOSEPT PLUS with HydraGlyde

Interventions

Lehfilcon A contact lensesDEVICE

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

Also known as: TOTAL30®
AOHP, then TOTAL30TOTAL30, then AOHP
Senofilcon A contact lensesDEVICE

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

Also known as: ACUVUE OASYS® with HYDRACLEAR® Plus, AOHP
AOHP, then TOTAL30TOTAL30, then AOHP
AOSEPT PLUS with HydraGlydeDEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Also known as: AOSEPT® PLUS with HYDRAGLYDE®
AOHP, then TOTAL30TOTAL30, then AOHP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurolens Research

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Senior Clinical Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Trial Lead, Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 27, 2021

Study Start

January 12, 2022

Primary Completion

June 14, 2022

Study Completion

June 14, 2022

Last Updated

June 18, 2023

Results First Posted

June 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)