Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)

• Registration Number: NCT01180777
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-01
• Primary Completion: 2010-08-01
• Study Completion: 2010-08-01
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Results First Submitted: 2013-11-13
• Results First Submitted QC: 2014-01-16
• Results First Posted: 2014-03-05
• Status Verified: 2017-08
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)	etafilcon A (A)	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.
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)	etafilcon A (C)	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.
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)	etafilcon A (B)	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.
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)	etafilcon A (C)	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.
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)	etafilcon A (B)	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.
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)	etafilcon A (C)	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.
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)	etafilcon A (B)	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.
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)	etafilcon A (B)	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.
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)	etafilcon A (C)	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.
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)	etafilcon A (B)	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.
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)	etafilcon A (A)	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.
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)	etafilcon A (A)	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.
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)	etafilcon A (A)	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.
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)	etafilcon A (C)	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.
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)	etafilcon A (A)	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.
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)	etafilcon A (A)	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.
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)	etafilcon A (B)	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.
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)	etafilcon A (C)	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.

Primary Outcome Measures

Name	Time	Method
Lens Fit Acceptance	10-15 minutes post lens fit	Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

Secondary Outcome Measures

Name	Time	Method
Binocular Snellen Visual Acuity (VA)	10-15 minutes post lens fit	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	After 6-9 days of lens wear	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.