Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

September 21, 2017 updated by: CooperVision, Inc.
The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens 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 will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

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.
90

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 Kingdom
    • Bristol
      • Chew Magna, Bristol, United Kingdom, BS40 8PR
        • Brock & Houlford
    • Dorset
      • Broadstone, Dorset, United Kingdom, BH18 8DP
        • Tempany's Boutique Opticians
    • Lancashire
      • Rawtenstall, Lancashire, United Kingdom, BB4 7QN
        • David Gould Opticians
  • United States
    • California
      • Whittier, California, United States, 90606
        • Golden Optometric Group
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Complete Eye Care of Medina

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
  • Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
  • Spectacle cylinder 0.75D in both eyes.
  • Correctable to 6/9 (20/30) in both eyes
  • Be between 18 and 50 years of age (inclusive)
  • Able to read, comprehend and sign an informed consent
  • Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
  • Willing to comply with the wear and study visit schedule

Exclusion:

  • Existing Biofinity or Ultra wearers
  • Any active corneal infection, injury or inflammation
  • Systemic or ocular allergies, which might interfere with Contact Lens wear
  • Systemic disease, which might interfere with Contact Lens wear
  • Ocular disease, which might interfere with Contact Lens wear
  • Strabismus or amblyopia
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant or lactating
  • Use of systemic/topical medication contraindicating Contact Lens wear
  • Diabetic
  • Site employees or family members of site employees

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Active Comparator: comfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
Device: comfilcon A
contact lens
Active Comparator: samfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
Device: samfilcon A
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
Comfort
Time Frame: Baseline, 2 weeks, 4 weeks
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Baseline, 2 weeks, 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
Comfortable Wearing Time Via SMS (Short Message Service)
Time Frame: Days 3, 12, 26
Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Days 3, 12, 26
Wearing Times
Time Frame: Baseline, 2 weeks, 4 weeks
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Baseline, 2 weeks, 4 weeks
Deterioration in Comfort
Time Frame: Baseline, 2 weeks, 4 weeks
Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent
Baseline, 2 weeks, 4 weeks
Vision Quality
Time Frame: Baseline, 2 weeks, 4 weeks
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Baseline, 2 weeks, 4 weeks
Overall Lens Handling
Time Frame: Baseline, 2 weeks, 4 weeks
Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Baseline, 2 weeks, 4 weeks
Biomicroscopy Scores
Time Frame: Baseline, 2 weeks, 4 weeks
Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Baseline, 2 weeks, 4 weeks
Lens Surface Wetting
Time Frame: Baseline, 2 weeks, 4 weeks
Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
Baseline, 2 weeks, 4 weeks
Film Deposits
Time Frame: 2 weeks and 4 weeks
Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.
2 weeks and 4 weeks
White Spot Deposits
Time Frame: 2 weeks and 4 weeks
Number of white spot deposits for comfilcon A and samfilcon A lenses.
2 weeks and 4 weeks
Visual Acuity (VA)
Time Frame: Baseline, 2 weeks, 4 weeks
Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Baseline, 2 weeks, 4 weeks
Lens Centration
Time Frame: Baseline, 2 weeks, 4 weeks
Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)
Baseline, 2 weeks, 4 weeks
Corneal Coverage
Time Frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up

Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.

Yes = coverage at all times or No = coverage incomplete
Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Post-Blink Movement
Time Frame: Baseline, 2 weeks, 4 weeks
Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Baseline, 2 weeks, 4 weeks
Primary Gaze Lag
Time Frame: Baseline, 2 weeks, and 4 weeks
Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Baseline, 2 weeks, and 4 weeks
Lens Tightness Push-up
Time Frame: Baseline, 2 weeks, 4 weeks

Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.

Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support
Baseline, 2 weeks, 4 weeks
Overall Fit Acceptance
Time Frame: Baseline, 2 weeks, 4 weeks
Overall fit acceptance for comfilcon A and samfilcon A lenses. 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, 2 weeks, 4 weeks
Dryness
Time Frame: Baseline, 2 weeks, 4 weeks
Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry
Baseline, 2 weeks, 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: Graeme Young, VisionCare

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.
August 1, 2015

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.
February 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.
March 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).
August 31, 2015

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.
September 3, 2015

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.
September 4, 2015

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.
October 24, 2017

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.
September 21, 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.
September 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-59 (VISA-406)

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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