Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
1 other identifier
interventional
64
1 country
6
Brief Summary
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
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 Sep 2021
Shorter than P25 for not_applicable
6 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
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 9, 2021
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2021
CompletedDecember 7, 2021
December 1, 2021
2 months
August 31, 2021
December 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Day 1, 10 minutes after lens insertion, each product
Study Arms (2)
P1fA, then MyDay Toric
OTHERVerofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
MyDay Toric, then P1fA
OTHERStenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
Interventions
Soft contact lenses for optical correction of astigmatism, used as indicated
Soft contact lenses for optical correction of astigmatism, used as indicated
Eligibility Criteria
You may qualify if:
- Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
You may not qualify if:
- Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
- Current wear of spherical contact lenses.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (6)
Alcon Investigator 6565
Maitland, Florida, 32751, United States
Alcon Investigator 6567
Pittsburg, Kansas, 66762, United States
Alcon Investigator 8097
Sterling Heights, Michigan, 48312, United States
Alcon Investigator 6313
Powell, Ohio, 43065, United States
Alcon Investigator 6401
Warwick, Rhode Island, 02888, United States
Alcon Investigator 6353
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Vision Care
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 9, 2021
Study Start
September 28, 2021
Primary Completion
November 29, 2021
Study Completion
November 29, 2021
Last Updated
December 7, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share