Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
1 other identifier
interventional
119
1 country
8
Brief Summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
8 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
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedResults Posted
Study results publicly available
May 13, 2021
CompletedOctober 19, 2021
September 1, 2021
4 months
November 25, 2019
April 22, 2021
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Distance VA (logMAR) With Study Lenses - Completed Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
Study Arms (2)
LID018869
EXPERIMENTALLehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Biofinity
ACTIVE COMPARATORComfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Interventions
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
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.
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 contact lenses.
- Monovision contact lens wearers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (8)
Alcon Investigative Site
Longwood, Florida, 32779, United States
Alcon Investigative Site
Maitland, Florida, 32751, United States
Alcon Investigative Site
Orlando, Florida, 32803, United States
Alcon Investigative Site
Bloomington, Illinois, 61704, United States
Alcon Investigative Site
Medina, Minnesota, 55340, United States
Alcon Investigative Site
Granville, Ohio, 43023, United States
Alcon Investigative Site
Memphis, Tennessee, 38111, United States
Alcon Investigative Site
Memphis, Tennessee, 38119, 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
CDMA Project Lead, 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
November 25, 2019
First Posted
November 26, 2019
Study Start
January 28, 2020
Primary Completion
June 10, 2020
Study Completion
June 10, 2020
Last Updated
October 19, 2021
Results First Posted
May 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share