A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

September 22, 2020 updated by: CooperVision, Inc.

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

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 will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism 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.
23

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
      • Campbell, California, United States, 95008
        • Family Eye Care 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

18 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 they:

    1. Are at least 18 years of age and have full legal capacity to volunteer;
    2. Have read and signed an information consent letter;
    3. Are willing and able to follow instructions and maintain the appointment schedule;
    4. Are an adapted soft contact lens wearer;

    5. Require spectacle lens powers in both eyes;

      1. Sphere: between -1.75 to -6.00 diopters and
      2. Astigmatism: between -1.00 to -2.25 and
      3. Axis: 180 ± 20 degrees
    6. Are willing to wear contact lenses in both eyes;
    7. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
    8. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.

Exclusion Criteria:

  • A person will be excluded from the study if they:

    1. Are participating in any concurrent clinical or research study;
    2. Have any known active* ocular disease and/or infection;
    3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
    4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
    5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
    6. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
    7. Are aphakic;
    8. Have undergone refractive error 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
  • 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: Sapphire contact lenses
Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.
Device: Sapphire contact lenses
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
ACTIVE_COMPARATOR: senofilcon A
Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.
Device: senofilcon A contact lenses
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

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 Ratings for Comfort
Time Frame: Baseline (10 minutes post lens settling)
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort
Time Frame: 2 weeks
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
2 weeks
Subjective Ratings for Comfort Preference
Time Frame: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference
Time Frame: 2 weeks
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
2 weeks
Subjective Assessment of Visual Quality
Time Frame: Baseline (10 minutes post lens settling)
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Baseline (10 minutes post lens settling)
Subjective Assessment of Visual Quality
Time Frame: 2 weeks
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
2 weeks
Subjective Assessment of Overall Satisfaction
Time Frame: Baseline (10 minutes post lens settling)
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Baseline (10 minutes post lens settling)
Subjective Assessment of Overall Satisfaction
Time Frame: 2 weeks
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
2 weeks
Subjective Overall Preference
Time Frame: Baseline (10 minutes post lens settling)
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Baseline (10 minutes post lens settling)
Subjective Overall Preference
Time Frame: 2 weeks
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
2 weeks

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: Michel Guillon, Ocular Technology 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

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.
September 1, 2015

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.
February 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.
April 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).
September 4, 2015

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.
September 17, 2015

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.
September 21, 2015

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 19, 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 22, 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.
  • CV-15-15

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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