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Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

Primary Purpose

Refractive Errors, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A contact lenses
Nesofilcon A contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Daily disposable contact lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
  • Successful wear of spherical 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.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 6565
  • Alcon Investigator 6402
  • Alcon Investigator 6313
  • Alcon Investigator 8028

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PRECISION1, then Biotrue ONEday

Biotrue ONEday, then PRECISION1

Arm Description

Verofilcon A contact lenses worn first, with nesofilcon 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.

Nesofilcon 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2020
Last Updated
October 27, 2021
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04527978
Brief Title
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Official Title
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Detailed Description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Myopia
Keywords
Daily disposable contact lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRECISION1, then Biotrue ONEday
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with nesofilcon 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.
Arm Title
Biotrue ONEday, then PRECISION1
Arm Type
Other
Arm Description
Nesofilcon 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.
Intervention Type
Device
Intervention Name(s)
Verofilcon A contact lenses
Other Intervention Name(s)
PRECISION1™
Intervention Description
Spherical soft contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Nesofilcon A contact lenses
Other Intervention Name(s)
Biotrue ONEday, Bausch + Lomb Biotrue® ONEday
Intervention Description
Spherical soft contact lenses for daily disposable wear
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) With Study Lenses
Description
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.
Time Frame
Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form. Successful wear of spherical 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. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any ocular condition that contraindicates contact lens wear. Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Project Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6402
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 8028
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

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