Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Myopia Clinical Trial

Official title:

Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180777
• Other study ID #: CR-1579AP
• Status: Completed
• Phase: N/A
• Start date: July 1, 2010
• Est. completion date: August 1, 2010

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 1, 2010
• Est. primary completion date: August 1, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A (A)
Daily wear contact lens
• etafilcon A (B)
Daily wear contact lens
• etafilcon A (C)
Daily wear contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Fit Acceptance	Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.	10-15 minutes post lens fit
Secondary	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.	10-15 minutes post lens fit
Secondary	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.	After 6-9 days of lens wear