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Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180777
First Posted: August 12, 2010
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Condition Intervention
Myopia Device: etafilcon A (A) Device: etafilcon A (B) Device: etafilcon A (C)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 95
Actual Study Start Date: July 1, 2010
Study Completion Date: August 1, 2010
Primary Completion Date: August 1, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (C)
etafilcon A (A)/etafilcon A (C)/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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (C)
etafilcon A (C)/etafilcon A (A)/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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (C)
etafilcon A (B)/etafilcon A (C)/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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (C)
etafilcon A (C)/etafilcon A (B)/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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (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 (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.
Device: etafilcon A (A)
Daily wear contact lens
Other Name: printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Name: printed etafilcon A Lens PVP (C)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180777


Locations
United States, California
Cupertino, California, United States, 95014
Los Angeles, California, United States, 90049
San Jose, California, United States, 95131
United States, Florida
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32256
Orlando, Florida, United States, 32792
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01180777     History of Changes
Other Study ID Numbers: CR-1579AP
First Submitted: August 3, 2010
First Posted: August 12, 2010
Results First Submitted: November 13, 2013
Results First Posted: March 5, 2014
Last Update Posted: October 2, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Povidone
Plasma Substitutes
Blood Substitutes