Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

July 18, 2017 updated by: CooperVision, Inc.
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

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.

Detailed Description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

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.
35

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

  • Spain
      • Valencia, Spain, 46100
        • Optometry Research Group (GIO) Optics Department, University of Valencia

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

Yes

Genders Eligible for Study

All

Description

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age
  • Has had a self-reported visual exam in the last two years
  • Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
  • Has a contact lens spherical prescription between -1.00 to - 6.00
  • Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood, and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria

A person will be excluded from the study if he/she:

  • Is not a habitual wearer of enfilcon A lenses
  • Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 3-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

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.
No Intervention: enfilcon A (habitual)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
Experimental: fanfilcon A (test)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
Device: fanfilcon A (test)
contact lens

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 - Centration
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Baseline, 1 week, 2 weeks, and 4 weeks
Lens Fit - Post-blink Movement
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Baseline, 1 week, 2 weeks, and 4 weeks
Lens Tightness on Push-up
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Baseline, 1 week, 2 weeks, and 4 weeks
Overall Fit Acceptance
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
Baseline, 1 week, 2 weeks, and 4 weeks

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
Overall Comfort
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.
Baseline, 1 week, 2 weeks, and 4 weeks
Dryness Overall
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.
Baseline, 1 week, 2 weeks, and 4 weeks
Handling
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Baseline, 1 week, 2 weeks, and 4 weeks
Overall Vision Satisfaction
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.
Baseline, 1 week, 2 weeks, and 4 weeks
Overall Satisfaction
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.
Baseline, 1 week, 2 weeks, and 4 weeks
Lens Preference Overall
Time Frame: 1 week, 2 weeks, and 4 weeks
Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).
1 week, 2 weeks, and 4 weeks
Wearing Times
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.
Baseline, 1 week, 2 weeks, and 4 weeks
Conjunctival Staining
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).
Baseline, 1 week, 2 weeks, and 4 weeks
Corneal Staining
Time Frame: Baseline, 1 week, 2 weeks, and 4 weeks
Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.
Baseline, 1 week, 2 weeks, and 4 weeks

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.
CooperVision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Montés-Mico, O.D., PhD, Optometry Research Group (GIO) University of Valencia

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

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.
January 1, 2016

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.
March 1, 2016

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.
May 1, 2016

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).
January 28, 2016

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.
January 28, 2016

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.
February 1, 2016

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.
February 5, 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.
July 18, 2017

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.
July 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.
  • EX-MKTG-55 (CV-15-09)

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