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Completed

NCT Number: NCT01180777

Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cupertino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etafilcon A (A)

Device

Daily wear contact lens

Other names: printed etafilcon A Lens with PVP (A)

etafilcon A (B)

Device

Daily wear contact lens

Other names: printed etafilcon A Lens PVP (B)

etafilcon A (C)

Device

Daily wear contact lens

Other names: printed etafilcon A Lens PVP (C)

Primary outcomes

  1. Lens Fit Acceptance

    Time frame: 10-15 minutes post lens fit

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

Secondary outcomes

  1. Binocular Snellen Visual Acuity (VA)

    Time frame: 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.

  2. Corneal Staining

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 12, 2010
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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