Comparing the Performance of 1 Day Multifocal Contact Lenses

June 18, 2021 updated by: CooperVision, Inc.
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

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

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

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.
60

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
      • San Diego, California, United States, 92131
        • Scripps Poway Eyecare
      • Whittier, California, United States, 90606
        • Golden Optometric Group
    • Florida
      • Sarasota, Florida, United States, 34237
        • Golden Vision
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Center

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

42 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Is at least 42 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Self reports having a full eye examination in the previous two years;
  4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
  5. Is willing and able to follow instructions and maintain the appointment schedule;
  6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
  7. Has refractive astigmatism no higher than -0.75DC;
  8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
  9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria:

  1. Is participating in any concurrent clinical or research study;
  2. Habitually wears one of the study contact lenses;
  3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
  4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  8. Has undergone refractive error surgery or intraocular surgery.

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: 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.
Experimental: Lens A (Test)
Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.
Device: Lens A
Subjects will be randomized to wear Lens A (test) for 2 weeks.
Other Names:
  • FDA Approved, non-marketed, daily disposable multifocal lens
Device: Lens B
Subjects will be randomized to wear Lens B (control) for 2 weeks.
Other Names:
  • FDA Approved, daily disposable multifocal lens
Device: Habitual Lenses
All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Lens B (Control)
Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Device: Lens A
Subjects will be randomized to wear Lens A (test) for 2 weeks.
Other Names:
  • FDA Approved, non-marketed, daily disposable multifocal lens
Device: Lens B
Subjects will be randomized to wear Lens B (control) for 2 weeks.
Other Names:
  • FDA Approved, daily disposable multifocal lens
Device: Habitual Lenses
All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Habitual Lenses
All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.
Device: Habitual Lenses
All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and 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
Subjective At-home Ratings for Ease of Lens Handling for Insertion
Time Frame: Day 13
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
Day 13

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: Wayne Golden, Golden Vision
  • Principal Investigator: Keith Wan, Scripps Poway Eyecare
  • Principal Investigator: Shane Kannarr, Kannarr Eye Care
  • Principal Investigator: David Ardaya, Golden Optometric Group

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 27, 2020

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.
December 7, 2020

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.
December 30, 2020

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 24, 2020

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 24, 2020

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.
June 26, 2020

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 22, 2021

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, 2021

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.
June 1, 2021

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-109

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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