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Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

Primary Purpose

Refractive Error, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A contact lenses
Somofilcon 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 Error focused on measuring Visual acuity, VA, Daily disposable contact lenses

Eligibility Criteria

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

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
  • Willing and able to attend all scheduled study visits as required per protocol.
  • Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

DDT2, then Clariti

Clariti, then DDT2

Arm Description

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Outcomes

Primary Outcome Measures

Least Squares Mean Distance Visual Acuity With Study Lenses
Visual acuity was assessed and 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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2019
Last Updated
June 25, 2020
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03888482
Brief Title
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Official Title
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.
Detailed Description
Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DDT2, then Clariti
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Arm Title
Clariti, then DDT2
Arm Type
Other
Arm Description
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Verofilcon A contact lenses
Other Intervention Name(s)
DDT2
Intervention Description
Investigational daily disposable soft contact lenses
Intervention Type
Device
Intervention Name(s)
Somofilcon A contact lenses
Other Intervention Name(s)
clariti® 1 day, Clariti
Intervention Description
Commercially available daily disposable soft contact lenses
Primary Outcome Measure Information:
Title
Least Squares Mean Distance Visual Acuity With Study Lenses
Description
Visual acuity was assessed and 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.
Time Frame
Day 8, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board. Willing and able to attend all scheduled study visits as required per protocol. Current wearer of spherical soft contact lenses. Key Exclusion Criteria: Any ocular condition that contraindicates contact lens wear. Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.
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 Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Alcon Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigative Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigative Site
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

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