Comparison of Two Daily Disposable Soft Contact Lenses

September 14, 2020 updated by: CooperVision, Inc.

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study 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 was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

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.
55

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
      • Pleasanton, California, United States, 94588
        • CooperVision Inc.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. They are between 18 and 40 years of age (inclusive).
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
  5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
  6. They own a wearable pair of spectacles and wear them on the day of the initial visit.
  7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

  1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breastfeeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
  9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this 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: 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.
Active Comparator: midafilcon A
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
Device: midafilcon A
midafilcon A 1 day daily disposable contact lens
Active Comparator: somofilcon A
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
Device: somofilcon A
somofilcon A 1 day daily disposable 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 - Horizontal Centration
Time Frame: Baseline
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Baseline
Lens Fit - Horizontal Centration
Time Frame: One Week
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
One Week
Lens Fit - Vertical Centration
Time Frame: Baseline
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Baseline
Lens Fit - Vertical Centration
Time Frame: One Week
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
One Week
Lens Fit - Corneal Coverage
Time Frame: Baseline
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Baseline
Lens Fit - Corneal Coverage
Time Frame: One Week
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
One Week
Lens Fit - Lens Movement
Time Frame: Baseline
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Baseline
Lens Fit - Lens Movement
Time Frame: One Week
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
One Week

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
Subjective Score for Vision
Time Frame: Baseline
Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Baseline
Subjective Score for Vision
Time Frame: One week
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
One week

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: Philip Morgan, PhD MCOptom FAAO FBCLA, Eurolens Research

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.
February 8, 2019

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 30, 2019

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.
September 18, 2019

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).
December 13, 2018

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.
December 17, 2018

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.
December 19, 2018

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 8, 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.
September 14, 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.
September 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.
  • EX-MKTG-99 (C18-649)

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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