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Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Primary Purpose

Myopia, Refractive Errors

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 Myopia focused on measuring soft contact lenses, vision, eyesight

Eligibility Criteria

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

Inclusion Criteria:

  • Understand and sign an Informed Consent Form;
  • Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Eye condition or injury, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Currently wearing clariti® 1 day contact lenses;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

DD T2, then Clariti 1 Day

Clariti 1 Day, then DD T2

Arm Description

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.

Outcomes

Primary Outcome Measures

Overall Quality of Vision
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2018
Last Updated
March 14, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03518008
Brief Title
Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Official Title
Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
June 11, 2018 (Actual)
Study Completion Date
June 11, 2018 (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 is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors
Keywords
soft contact lenses, vision, eyesight

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DD T2, then Clariti 1 Day
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
Arm Title
Clariti 1 Day, then DD T2
Arm Type
Other
Arm Description
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
verofilcon A contact lenses
Other Intervention Name(s)
DD T2
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 1 Day
Intervention Description
Commercially available daily disposable soft contact lenses
Primary Outcome Measure Information:
Title
Overall Quality of Vision
Description
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Time Frame
Day 8, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and sign an Informed Consent Form; Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; Best-corrected visual acuity (BCVA) 20/25 or better in each eye; Willing to stop wearing habitual contact lenses for the duration of study participation; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator; Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; Refractive, ocular, or intraocular surgery, as specified in the protocol; Eye condition or injury, as specified in the protocol; Current or history of intolerance, hypersensitivity, or allergy to any component of the study products; Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear; Currently wearing clariti® 1 day contact lenses; Habitually wearing monovision or multifocal lenses during the last 3 months; Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Two Daily Disposable Soft Contact Lenses

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