Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
1 other identifier
interventional
153
1 country
11
Brief Summary
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
11 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
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedResults Posted
Study results publicly available
November 2, 2023
CompletedNovember 2, 2023
October 1, 2023
2 months
July 29, 2022
October 9, 2023
October 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Day 8 of each study lens type worn during the corresponding crossover period
Study Arms (2)
P1fA, then MDT
OTHERVerofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.
MDT, then P1fA
OTHERStenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.
Interventions
Soft contact lenses for optical correction of ametropia and astigmatism
Soft contact lenses for optical correction of ametropia and astigmatism
Eligibility Criteria
You may qualify if:
- Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Able to wear contact lenses within a range of sphere \& cylinder power and axes.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
You may not qualify if:
- Current or previous P1fA and MDT habitual lens wearers.
- Monovision and multifocal lens wearers.
- Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (11)
Kurata Eyecare Center
Los Angeles, California, 90012, United States
Sabal Eye Care
Longwood, Florida, 32779, United States
Drs. Giedd, P.A.
Maitland, Florida, 32751, United States
Vision Health Institute
Orlando, Florida, 32803, United States
Franklin Park Eye Center
Franklin Park, Illinois, 60131, United States
Kannarr Eye Care
Pittsburg, Kansas, 66762, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204, United States
Wesley Optometric Consulting
Medina, Minnesota, 55340, United States
ProCare Vision Center
Granville, Ohio, 43023, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, CRD Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Sr. Clinical Trial 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 1, 2022
Study Start
September 13, 2022
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
November 2, 2023
Results First Posted
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share