NCT04528017

Brief Summary

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Clariti 1-Day contact lenses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 11, 2021

Completed
Last Updated

November 11, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

August 24, 2020

Results QC Date

September 21, 2021

Last Update Submit

October 14, 2021

Conditions

Refractive ErrorsMyopia

Keywords

Daily disposable contact lenses

Outcome Measures

Primary Outcomes (1)

  • Distance Visual Acuity (VA) With Study Lenses

    Distance 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. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

    Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Study Arms (2)

PRECISION1, then Clariti 1-Day

OTHER

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Device: Verofilcon A contact lensesDevice: Somofilcon A contact lenses

Clariti 1-Day, then PRECISION1

OTHER

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Device: Verofilcon A contact lensesDevice: Somofilcon A contact lenses

Interventions

Verofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: PRECISION1™
Clariti 1-Day, then PRECISION1PRECISION1, then Clariti 1-Day
Somofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: CooperVision® clariti® 1 day, Clariti 1-Day
Clariti 1-Day, then PRECISION1PRECISION1, then Clariti 1-Day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
  • Successful wear of 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 contact lenses for at least 16 hours per day on one of the days with each lens type.

You may not qualify if:

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of PRECISION1, Clariti 1-Day, or DAILIES TOTAL1 contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6402

Medina, Minnesota, 55340, United States

Location

Alcon Investigator 6313

Powell, Ohio, 43065, United States

Location

Alcon Investigator 8028

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
CDMA Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • CDMA Project Lead, Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

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

August 24, 2020

First Posted

August 27, 2020

Study Start

September 1, 2020

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

November 11, 2021

Results First Posted

November 11, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(4)