A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

July 20, 2020 updated by: CooperVision, Inc.
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

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 study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

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.
12

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
      • Berkeley, California, United States, 94704
        • Clinical Research Center, University of California, Berkeley

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

  • Has had a self-reported oculo-visual examination in the last two years
  • Is 50 years of age or greater and has full legal capacity to volunteer
  • Is able to read and understand the informed consent
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
  • Near Add Power requirement of +2.25D or greater
  • Has spectacle cylinder 0.75 D in both eyes
  • Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
  • Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
  • Has clear corneas and no active ocular disease
  • Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

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

  • Has never worn contact lenses before
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or abnormality that would affect the wearing of contact lenses
  • Is aphakic (i.e. missing their natural lens inside their eye)
  • Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
  • 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: 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: comfilcon A Extended Range test lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
Device: comfilcon A Extended Range test lens
contact lenses
Device: comfilcon A control lens
contact lenses
Active Comparator: comfilcon A control lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
Device: comfilcon A Extended Range test lens
contact lenses
Device: comfilcon A control lens
contact lenses

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
Visual Acuity
Time Frame: 4 days
Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.
4 days
Visual Performance
Time Frame: 4 days
Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
4 days

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
Comfort
Time Frame: Baseline
Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Baseline
Comfort
Time Frame: 4 days
Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
4 days
Dryness
Time Frame: Baseline
Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Baseline
Dryness
Time Frame: 4 days
Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
4 days
Subjective Preference for Comfort
Time Frame: 4 days
Subjective preference for comfort for test and control contact lenses.
4 days
Subjective Satisfaction
Time Frame: 4 days
Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
4 days
Subjective Preference for Near Vision
Time Frame: 4 days
Subjective preference for Near Vision for test and control contact lenses.
4 days
Subjective Preference for Intermediate Vision
Time Frame: 4 days
Subjective preference for intermediate vision for test and control contact lenses.
4 days
Subjective Preference for Distance Vision
Time Frame: 4 days
Subjective preference for distance vision for test and control contact lenses.
4 days
Subjective Overall Vision Preference
Time Frame: 4 days
Subjective overall vision preference for test and control contact lenses.
4 days
Average Daily Wearing Time
Time Frame: 4 days
Average daily wearing time for test and control lens is assessed in hours.
4 days
Lens Fit
Time Frame: 4 days
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit.
4 days
Lens Handling
Time Frame: 4 Days
Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle).
4 Days
Bulbar Hyperemia
Time Frame: 4 days
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia
4 days
Limbal Hyperemia
Time Frame: 4 days
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia
4 days

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.
  • Study Director: Meng C Lin, PhD, CRC, UC Berkeley

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.
March 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.
May 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.
August 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).
March 21, 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.
March 21, 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.
March 25, 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.
July 30, 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.
July 20, 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.
July 1, 2020

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.
  • CV-16-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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