Evaluation of Three Daily Disposable Contact Lenses

July 14, 2017 updated by: Johnson & Johnson Vision Care, Inc.
This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.

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.

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.
78

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

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form;
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
  • The subject must be willing and able to follow instructions and maintain the appointment schedule;
  • The subject must be between the age of 18 and 40 years (inclusive);
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
  • The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;
  • The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
  • The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment;
  • The subject must own a wearable pair of spectacles and wear them the day of the initial visit;
  • The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type);
  • The subject must be willing to wear the study lenses for a minimum eight hours per day.

Exclusion Criteria:

  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
  • Any active ocular infection;
  • Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;
  • Any participants whose habitual contact lenses are used as an extended wear regimen;
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry;
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.);
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear;
  • Any known hypersensitivity or allergic reaction to the study products;
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment;
  • Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

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: PREVENTION
  • 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: Lens 1/ Lens 2/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday
ACTIVE_COMPARATOR: Lens 1 / Lens 3 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday
ACTIVE_COMPARATOR: Lens 2/ Lens 3/ Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday
ACTIVE_COMPARATOR: Lens 2 / Lens 1/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday
ACTIVE_COMPARATOR: Lens 3 / Lens 1 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday
ACTIVE_COMPARATOR: Lens 3 / Lens 2 / Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • 1-Day Acuvue® Moist®
Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Dailies® AquaComfort Plus®
Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Names:
  • Biotrue ONEday

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
Overall Comfort
Time Frame: 2- Week Follow-up
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2- Week Follow-up

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.
Johnson & Johnson Vision Care, Inc.

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.
September 3, 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.
January 18, 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.
January 18, 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 22, 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.
October 2, 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.
October 5, 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.
July 17, 2017

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 14, 2017

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, 2017

More Information

Terms related to this study

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.
  • CR-5735

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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