Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
1 other identifier
interventional
158
1 country
14
Brief Summary
The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
14 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
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2021
CompletedResults Posted
Study results publicly available
February 24, 2022
CompletedMarch 29, 2022
March 1, 2022
5 months
June 5, 2020
February 3, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to 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.
Week 1 Follow-Up
Secondary Outcomes (1)
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up
Week 1 Follow-Up
Study Arms (2)
LID018869
EXPERIMENTALLehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Biofinity
ACTIVE COMPARATORComfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Interventions
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Eligibility Criteria
You may qualify if:
- Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
- Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
You may not qualify if:
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Habitually wearing Biofinity lenses;
- Monovision or multifocal contact lens wearers;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (14)
Alcon Investigative Site
Los Angeles, California, 90012, United States
Alcon Investigative Site
Novato, California, 94945, United States
Alcon Investigative Site
Oakland, California, 94513, United States
Alcon Investigative Site
Oakland, California, 94607, United States
Alcon Investigative Site
San Francisco, California, 94122, United States
Alcon Investigative Site
Orlando, Florida, 32803, United States
Alcon Investigative Site
West Palm Beach, Florida, 33405, United States
Alcon Investigative Site
Downers Grove, Illinois, 60515, United States
Alcon Investigative Site
Louisville, Kentucky, 40221, United States
Alcon Investigative Site
New York, New York, 10036, United States
Alcon Investigative Site
Cleveland, Ohio, 44106, United States
Alcon Investigative Site
Boiling Springs, South Carolina, 29316, United States
Alcon Investigative Site
Plano, Texas, 75093, United States
Alcon Investigative Site
Wichita Falls, Texas, 76308, 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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
October 1, 2020
Primary Completion
February 22, 2021
Study Completion
May 18, 2021
Last Updated
March 29, 2022
Results First Posted
February 24, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share