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Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Primary Purpose

Refractive Ametropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A control lens (1DM)
etafilcon A with print and PVP for light eyes (EALE)
etafilcon A with print and PVP for dark eyes (EADE)
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Ametropia

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy, female adult, at least 18 years of age, and no more than 34 years of age
  • The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
  • Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
  • Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
  • Any cylinder power must be: <=0.75D
  • Visual acuity must be best correctable to 20/25 or better for each eye
  • Must have normal eyes (no ocular medications or ocular infection of any type)
  • Must read and sign the Statement of Informed Consent
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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
  • Any color deficiencies (colorblindness) - to the best of the subject's knowledge
  • Pregnancy or lactation
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  • Subject presents with one dark iris color and one light iris color.
  • Subject has heterochromia iridis (a difference in color between parts of one iris).
  • The subject must not be an employee or family member of the clinical study site.

Sites / Locations

  • Advanced Optometry
  • James R Dugue, Optometrist
  • Advance Eye Care
  • Golden Vision
  • Eye Associates of Winter Park
  • Eye Care Associates
  • Kannarr Eye Care
  • Vision Care
  • Spectrum Eye Care
  • Sacco Eye Group
  • The Eye Care Group
  • Dr. David W Ferris and Associates
  • Wishnow Sugar Group
  • Isthmus Eye Care
  • Snowy Range Cision Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

EALE/1DM

1DM/EALE

EADE/1DM

1DM/EADE

Arm Description

etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.

etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.

etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.

etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.

Outcomes

Primary Outcome Measures

Monocular Visual Acuity
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Lens Fit Acceptance
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Corneal Staining of Grade 3 or 4
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2011
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01484028
Brief Title
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
Official Title
Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 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 study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EALE/1DM
Arm Type
Other
Arm Description
etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Arm Title
1DM/EALE
Arm Type
Other
Arm Description
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Arm Title
EADE/1DM
Arm Type
Other
Arm Description
etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Arm Title
1DM/EADE
Arm Type
Other
Arm Description
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Intervention Type
Device
Intervention Name(s)
etafilcon A control lens (1DM)
Other Intervention Name(s)
1-DAY ACUVUE MOIST Brand Contact Lenses
Intervention Description
A marketed daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A with print and PVP for light eyes (EALE)
Intervention Description
A daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A with print and PVP for dark eyes (EADE)
Intervention Description
A daily disposable contact lens
Primary Outcome Measure Information:
Title
Monocular Visual Acuity
Description
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Time Frame
Dispensing
Title
Lens Fit Acceptance
Description
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Time Frame
Dispensing
Title
Corneal Staining of Grade 3 or 4
Description
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.
Time Frame
After 7-9 days of lens wear

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy, female adult, at least 18 years of age, and no more than 34 years of age The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes Must have rated the Concept Statement positively (i.e., a rating of 4 or 5). Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D) Any cylinder power must be: <=0.75D Visual acuity must be best correctable to 20/25 or better for each eye Must have normal eyes (no ocular medications or ocular infection of any type) Must read and sign the Statement of Informed Consent Must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Ocular or systemic allergies or disease which might interfere with contact lens wear Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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 Any color deficiencies (colorblindness) - to the best of the subject's knowledge Pregnancy or lactation Diabetes Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV) Habitual contact lens type is toric, multifocal, or is worn as extended wear. Subject presents with one dark iris color and one light iris color. Subject has heterochromia iridis (a difference in color between parts of one iris). The subject must not be an employee or family member of the clinical study site.
Facility Information:
Facility Name
Advanced Optometry
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
James R Dugue, Optometrist
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Advance Eye Care
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93448
Country
United States
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34242
Country
United States
Facility Name
Eye Associates of Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Eye Care Associates
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Vision Care
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48826
Country
United States
Facility Name
Spectrum Eye Care
City
Jamestown
State/Province
New York
ZIP/Postal Code
14702
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
The Eye Care Group
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97526
Country
United States
Facility Name
Dr. David W Ferris and Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02887
Country
United States
Facility Name
Wishnow Sugar Group
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Isthmus Eye Care
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Snowy Range Cision Center
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82070
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

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