Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
1 other identifier
interventional
166
1 country
10
Brief Summary
The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedResults Posted
Study results publicly available
March 16, 2023
CompletedMarch 16, 2023
March 1, 2023
4 months
September 10, 2021
February 16, 2023
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. 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 a lower logMAR value indicating better visual acuity.
Day 30, each study lens type
Study Arms (2)
LID018869, then AOHP
OTHERLehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
AOHP, then LID018869
OTHERSenofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Interventions
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Eligibility Criteria
You may qualify if:
- Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Manifest cylinder less than or equal to 0.75 diopter in each eye.
- Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
You may not qualify if:
- Monovision or multifocal lens wearer.
- Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
- Routinely sleeps in habitual contact lenses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (10)
Dr. Elsa Pao, OD
Oakland, California, 94607, United States
Pacific Rims Optometry
San Francisco, California, 94127, United States
Sabal Eye Care
Longwood, Florida, 32779, United States
Vision Health Institute
Orlando, Florida, 32803, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
North Spartanburg Eye Center
Boiling Springs, South Carolina, 29316, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167, United States
Dr Christina R Chang & Associates, OD, PA
Plano, Texas, 75093, United States
Dawn M. Rakich, OD
San Antonio, Texas, 78213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CDMA Project Lead, Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Sr. Clinical Trial Lead, CDMA Vision Care
Alcon Research, LLC
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
September 10, 2021
First Posted
September 20, 2021
Study Start
November 2, 2021
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
March 16, 2023
Results First Posted
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share