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Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
delefilcon A
etafilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
  • The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
  • The subject must be a current successful soft contact lens wearer in both eyes
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.
  • The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
  • The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
  • The subject must require a visual correction in both eyes (no monofit or monovision allowed).
  • The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    1. No amblyopia.
    2. No evidence of lid abnormality or infection (including blepharitis/meibomitis).
    3. No conjunctival abnormality or infection.
    4. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
    5. No other active ocular disease.

Exclusion Criteria:

  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • No extended wear in the last 3 months.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
  • Employee or family member of the staff of the investigational site.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Delefilcon A/ Etafilcon A

Etafilcon A / Delefilcon A

Arm Description

6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear

6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

Outcomes

Primary Outcome Measures

Subject Reported Ease of Removal
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.

Secondary Outcome Measures

Subject Reported Overall Comfort
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.
Subject Reported Overall Vision
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.
Binocular Snellen Visual Acuity
Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.
Overall Corneal Staining
Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes.

Full Information

First Posted
August 16, 2012
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01669629
Brief Title
Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Official Title
Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Delefilcon A/ Etafilcon A
Arm Type
Experimental
Arm Description
6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
Arm Title
Etafilcon A / Delefilcon A
Arm Type
Experimental
Arm Description
6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
Intervention Type
Device
Intervention Name(s)
delefilcon A
Intervention Description
Daily wear soft contact lens for bilateral distance vision correction use.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
Daily wear soft contact lens for bilateral distance vision correction use.
Primary Outcome Measure Information:
Title
Subject Reported Ease of Removal
Description
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
Time Frame
6-10 Days
Secondary Outcome Measure Information:
Title
Subject Reported Overall Comfort
Description
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.
Time Frame
6-10 Days
Title
Subject Reported Overall Vision
Description
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.
Time Frame
6-10 Days
Title
Binocular Snellen Visual Acuity
Description
Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.
Time Frame
6-10 Days
Title
Overall Corneal Staining
Description
Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes.
Time Frame
6-10 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF). The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week. The subject must be a current successful soft contact lens wearer in both eyes The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye. The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes. The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. The subject must require a visual correction in both eyes (no monofit or monovision allowed). The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection (including blepharitis/meibomitis). No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation. No extended wear in the last 3 months. Diabetes. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV). Employee or family member of the staff of the investigational site.
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72116
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
City
Blue Springs
State/Province
Missouri
ZIP/Postal Code
64015
Country
United States
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
City
Chamberlain
State/Province
South Dakota
ZIP/Postal Code
57325
Country
United States
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States

12. IPD Sharing Statement

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Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

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