Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cupertino, California, United States, 95014
      • Los Angeles, California, United States, 90049
      • San Jose, California, United States, 95131
    • Florida
      • Jacksonville, Florida, United States, 32205
      • Jacksonville, Florida, United States, 32256
      • Orlando, Florida, United States, 32792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)
Other: 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 Names:
  • printed etafilcon A Lens with PVP (A)
Device: etafilcon A (B)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (B)
Device: etafilcon A (C)
Daily wear contact lens
Other Names:
  • printed etafilcon A Lens PVP (C)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10-15 minutes post lens fit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
10-15 minutes post lens fit
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.
After 6-9 days of lens wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Vision Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-1579AP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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