Clinical Evaluation of Multifocal Toric Contact Lenses

August 24, 2020 updated by: Johnson & Johnson Vision Care, Inc.
This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

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.
96

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
      • Whittier, California, United States, 90606
        • Golden Optometric Group
    • Florida
      • Orlando, Florida, United States, 32819
        • Bay Hill Eye Care
    • Hawaii
      • Kahului, Hawaii, United States, 96732
        • Lee & Leong Doctors of Optometry
    • New York
      • Jamestown, New York, United States, 14750
        • Spectrum Eyecare
      • Vestal, New York, United States, 13850
        • Sacco Eye Group
    • Ohio
      • Miamisburg, Ohio, United States, 45342
        • Miamisburg Vision Care
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
    2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
    3. The subject must be between 40 and 70 years of age.
    4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D.
    5. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye
    6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye
    7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye
    8. Subjects must own a wearable pair of spectacles if required for their distance vision
    9. The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration)
    10. The subject must already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".

Exclusion Criteria:

  1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear
  2. Pregnancy or lactation
  3. Currently diagnosed with diabetes
  4. Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV).
  5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions
  7. Any previous, or planned, ocular or intraocular surgery (eg, radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc)
  8. A history of amblyopia, strabismus or binocular vision abnormality
  9. Any ocular infection or inflammation
  10. Any ocular abnormality that may interfere with contact lens wear
  11. Use of any ocular medication, with the exception of rewetting drops
  12. History of herpetic keratitis
  13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
  14. Employee of clinical site (eg, Investigator, Coordinator, Technician).

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: Double

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.
Experimental: Sequence 1
etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 2
etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 3
etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 4
etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 5
etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 6
etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 7
etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 8
etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 9
etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control Lens
Experimental: Sequence 10
etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator)
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 2
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Tes Lens 3
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 4
Device: etafilcon A Investigational Toric Multifocal Contact Lens
Control 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
Overall Handling Comparison Between Test 1/Test 2 and Control
Time Frame: 15 minutes
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
15 minutes

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 Handling Comparison Between Test 3/Test 4 and Control
Time Frame: 15 minutes
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
15 minutes

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.
June 12, 2017

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.
July 21, 2017

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.
July 21, 2017

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).
June 30, 2017

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.
June 30, 2017

First Posted (Actual)

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.
July 5, 2017

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.
September 10, 2020

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.
August 24, 2020

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, 2020

More Information

Terms related to this study

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-5935

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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