Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: etafilcon A (C); Device: etafilcon A (B); Device: etafilcon A (A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180777

CR-1579AP

Details and patient eligibility

About

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Enrollment: 95 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 6 patient groups

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)

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

Other group

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.

Treatment:

Device: etafilcon A (A)

Device: etafilcon A (B)

Device: etafilcon A (C)