Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

NCT05431478 | Completed Results FDA Device

• 1 other identifier: CLL949-E005
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Conditions

Refractive Errors

Keywords

Myopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity With Study Lenses at Week 1 Follow-Up

  Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.

  Week 1, each wear period. A wear period was approximately 14 days.

Study Arms (2)

LID022821, then AOHP

OTHER

Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Device: Serafilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE

AOHP, then LID022821

OTHER

Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Device: Serafilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE

Interventions

Serafilcon A contact lenses DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Also known as: LID022821

AOHP, then LID022821; LID022821, then AOHP

Senofilcon A contact lenses DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Also known as: ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS, AOHP

AOHP, then LID022821; LID022821, then AOHP

CLEAR CARE DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Also known as: CLEAR CARE® Cleaning and Disinfecting Solution

AOHP, then LID022821; LID022821, then AOHP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye.
• Willing to stop wearing habitual contact lenses for the duration of study participation.

You may not qualify if:

• Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
• Habitual wear of AOHP contact lenses.
• Habitual wear of any daily disposable contact lenses.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Drs. Giedd, PA

Maitland, Florida, 32751, United States

Location

Wesley Optometric Consulting

Medina, Minnesota, 55340, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, CDMA 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 15, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)