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Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Primary Purpose

Myopia

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

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject must be at least 18 years of age and less than 40 years of age.
  2. The subject must be a light eye Caucasian female habitual soft contact lens wearer.
  3. The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
  4. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  5. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  6. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  7. Any cylinder power must be ≤ -0.75D.
  8. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  9. The subject must have normal eyes (no ocular medications or ocular infection of any type).
  10. The subject must read and sign the Statement of Informed Consent.
  11. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
  2. Systemic disease or use of medication which might interfere with contact lens wear.
  3. Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Any color deficiencies - to the best of the subject's knowledge.
  8. Pregnancy or lactation.
  9. Diabetes.
  10. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  11. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

etafilcon A (A)/etafilcon A (B)/etafilcon A (C)

etafilcon A (A)/etafilcon A (C)/etafilcon A (B)

etafilcon A (C)/etafilcon A (A)/etafilcon A (B)

etafilcon A (B)/etafilcon A (C)/etafilcon A (A)

etafilcon A (C)/etafilcon A (B)/etafilcon A (A)

etafilcon A (B)/etafilcon A (A)/etafilcon A (C)

Arm Description

Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.

Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.

Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.

Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.

Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.

Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.

Outcomes

Primary Outcome Measures

Lens Fit Acceptance
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

Secondary Outcome Measures

Binocular Snellen Visual Acuity (VA)
Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.
Corneal Staining
Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.

Full Information

First Posted
August 3, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01180777
Brief Title
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Official Title
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2010 (Actual)
Primary Completion Date
August 1, 2010 (Actual)
Study Completion Date
August 1, 2010 (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
The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

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

8. Arms, Groups, and Interventions

Arm Title
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
Arm Title
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
Arm Title
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
Arm Title
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
Arm Title
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
Arm Title
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)
Arm Type
Other
Arm Description
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
Intervention Type
Device
Intervention Name(s)
etafilcon A (A)
Other Intervention Name(s)
printed etafilcon A Lens with PVP (A)
Intervention Description
Daily wear contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A (B)
Other Intervention Name(s)
printed etafilcon A Lens PVP (B)
Intervention Description
Daily wear contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A (C)
Other Intervention Name(s)
printed etafilcon A Lens PVP (C)
Intervention Description
Daily wear contact lens
Primary Outcome Measure Information:
Title
Lens Fit Acceptance
Description
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.
Time Frame
10-15 minutes post lens fit
Secondary Outcome Measure Information:
Title
Binocular Snellen Visual Acuity (VA)
Description
Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.
Time Frame
10-15 minutes post lens fit
Title
Corneal Staining
Description
Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.
Time Frame
After 6-9 days of lens wear

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be at least 18 years of age and less than 40 years of age. The subject must be a light eye Caucasian female habitual soft contact lens wearer. The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible. 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 - 5.00D. Any cylinder power must be ≤ -0.75D. The subject must have visual acuity best correctable to 20/25+3 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 or use of medication which might interfere with contact lens wear. Clinically significant (grade 3 or worse) 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. Any color deficiencies - 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.
Facility Information:
City
Cupertino
State/Province
California
ZIP/Postal Code
95014
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95131
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32792
Country
United States

12. IPD Sharing Statement

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Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

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