Comparison of New Contact Lens With Current Marketed Lens

August 18, 2020 updated by: CooperVision, Inc.

Clinical Validation Study of Phoebe Lens

The purpose of this study is to validate the clinical performance of a new contact lens design.

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

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

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.
53

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
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Clinical Optical Research Lab (CORL)

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 35 years (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:

  • Between and 18 and 35 years of age and has full legal capacity to volunteer
  • Has had a self-reported oculo-visual examination in the last two years
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
  • Has a Contact Lens Refraction between -1.00D and -6.00D
  • Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
  • Currently wears soft contact lenses
  • Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
  • Has clear corneas and no active ocular disease
  • Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

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

  • Has never worn contact lenses before
  • Is wearing Monovision modality
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars
  • Is aphakic
  • 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
  • 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: Test lens
Subjects randomized to wear pair of test lens either first or second
Device: Phoebe test lens
Daily disposable contact lens
Other Names:
  • Test Lens
  • Phoebe Contact Lens
Device: stenfilcon A lens (control)
Daily disposable contact lens
Other Names:
  • MyDay daily disposable contact lens
ACTIVE_COMPARATOR: stenfilcon A lens (control)
Subjects randomized to wear pair of control lens either first or second
Device: Phoebe test lens
Daily disposable contact lens
Other Names:
  • Test Lens
  • Phoebe Contact Lens
Device: stenfilcon A lens (control)
Daily disposable contact lens
Other Names:
  • MyDay 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
Corneal Staining Extent
Time Frame: Baseline
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Baseline
Corneal Staining Extent
Time Frame: Day 3
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Day 3
Conjunctival Staining Score
Time Frame: Baseline
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Baseline
Conjunctival Staining Score
Time Frame: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Day 3
Palpebral Hyperemia on Upper Lid
Time Frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Baseline
Palpebral Hyperemia on Upper Lid
Time Frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Day 3
Palpebral Hyperemia on Lower Lid
Time Frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Baseline
Palpebral Hyperemia on Lower Lid
Time Frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Day 3
Palpebral Roughness Grade - Upper Lid
Time Frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Baseline
Palpebral Roughness Grade - Upper Lid
Time Frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Day 3
Palpebral Roughness Grade - Lower Lid
Time Frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Baseline
Palpebral Roughness Grade - Lower Lid
Time Frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Day 3

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
Distance Visual Acuity
Time Frame: Baseline (at lens dispense)
Distance visual acuity recorded in logMAR.
Baseline (at lens dispense)
Distance Visual Acuity
Time Frame: Day 3
Distance visual acuity recorded in logMAR.
Day 3
Near Visual Acuity
Time Frame: Baseline (at dispense)
Near visual acuity recorded in logMAR
Baseline (at dispense)
Near Visual Acuity
Time Frame: Day 3
Near visual acuity recorded in logMAR
Day 3
Vision Quality Rating
Time Frame: Baseline (at dispense)
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Baseline (at dispense)
Vision Quality Rating
Time Frame: Day 3
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Day 3

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: Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA, Clinical Optics Research Lab (CORL), Indiana University

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.
November 6, 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.
December 15, 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.
December 15, 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).
November 21, 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.
November 27, 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.
December 2, 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 2, 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 18, 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

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-17-60

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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