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Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Primary Purpose

Refractive Ametropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A with print and PVP for dark eyes (EAPVPDE)
etafilcon A control lens (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:

  • The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
  • The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
  • The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
  • The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  • The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  • The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
  • Any cylinder power must be:<=0.75D.
  • The subject must have visual acuity best correctable to 20/25 or better for each eye.
  • The subject must have normal eyes (no ocular medications or ocular infection of any type).
  • The subject must read and sign the Statement of Informed Consent.
  • The subject 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 (color blindness) - 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 is an employee or family member of the clinical study site.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

EAPVPDE/EADE

EADE/EAPVPDE

Arm Description

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

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

Outcomes

Primary Outcome Measures

Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

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
NCT01484054
Brief Title
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens
Official Title
Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark 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
To evaluate and compare the performance of a new contact lens to a marketed contact 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
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EAPVPDE/EADE
Arm Type
Other
Arm Description
etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
Arm Title
EADE/EAPVPDE
Arm Type
Other
Arm Description
etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
Intervention Type
Device
Intervention Name(s)
etafilcon A with print and PVP for dark eyes (EAPVPDE)
Intervention Description
A daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A control lens (EADE)
Intervention Description
A marketed daily disposable contact lens
Primary Outcome Measure Information:
Title
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
Description
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.
Time Frame
After 7 to 9 days of lens wear
Title
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
Description
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time Frame
After 7 to 9 days of lens wear
Title
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
Description
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time Frame
After 7 to 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: The subject must be a healthy adult at least 18 years of age and no more than 34 years of age. The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes). The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D. Any cylinder power must be:<=0.75D. The subject must have visual acuity best correctable to 20/25 or better for each eye. The subject must have normal eyes (no ocular medications or ocular infection of any type). The subject must read and sign the Statement of Informed Consent. The subject 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 (color blindness) - 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 is an employee or family member of the clinical study site.
Facility Information:
City
Bloomfield
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66207
Country
United States
City
Jamestown
State/Province
New York
ZIP/Postal Code
14750
Country
United States
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

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