Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01180777
First received: August 3, 2010
Last updated: January 16, 2014
Last verified: January 2014
  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: 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 Vistakon:

Primary Outcome Measures:
  • Lens Fit Acceptance [ Time Frame: 10-15 minutes post lens fit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Study Start Date: July 2010
Primary Completion Date: August 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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01180777     History of Changes
Other Study ID Numbers: CR-1579AP
Study First Received: August 3, 2010
Results First Received: November 13, 2013
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Povidone
Blood Substitutes
Hematologic Agents
Pharmacologic Actions
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014