Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

November 30, 2022 updated by: Johnson & Johnson Vision Care, Inc.
This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.

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.
302

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
      • Mission Viejo, California, United States, 92691
        • James R. Dugue Optometry
    • Florida
      • Maitland, Florida, United States, 32751
        • Maitland Vision Center
      • Orange Park, Florida, United States, 32073
        • Flora Chen Poveda, OD, PA
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Visual Eyes, Inc
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • VisionPoint Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • ABQ Eye Care
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Center
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group LLC
    • Texas
      • Houston, Texas, United States, 77054
        • Gulf Coast Vision Center, Inc.
      • Tyler, Texas, United States, 75703
        • Tyler Eye Associates

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 40 (inclusive) years of age at the time of screening.
  4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
  5. By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
  6. The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye.
  7. The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
  8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or breastfeeding
  2. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
  3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
  4. Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
  5. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
  6. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  7. Have a history of amblyopia or strabismus.
  8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
  9. Have clinically significant (Grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
  10. Have any ocular infection.

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.
Experimental: O1D/P1
Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1)
Device: ACUVUE Oasys 1-Day
TEST
Device: Precision 1
CONTROL
Experimental: P1/O1D
Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D)
Device: ACUVUE Oasys 1-Day
TEST
Device: Precision 1
CONTROL

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 (Phase I)
Time Frame: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
End of Day Comfort (Phase I)
Time Frame: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
End of Day Dryness (Phase I)
Time Frame: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
End of Day Comfort (Phase II)
Time Frame: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
End of Day Dryness (Phase II)
Time Frame: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Overall Comfort (Phase II)
Time Frame: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up

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 Throughout the Day (Phase II)
Time Frame: 1-Week Follow-up
Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Comfort While Using Digital Devices (Phase II)
Time Frame: 1-Week Follow-up
Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Dryness While Using Digital Devices (Phase II)
Time Frame: 1-Week Follow-up
Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Lens Awareness Upon Insertion (Phase II)
Time Frame: 1-Minute Post lens fitting
Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
1-Minute Post lens fitting
Comfort Upon Insertion (Phase II)
Time Frame: 1-Minute Post lens fitting
Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
1-Minute Post lens fitting
Overall Ease of Handling (Phase II)
Time Frame: 1-Week Follow-up
Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Ease of Insertion (Phase II)
Time Frame: 1-Week Follow-up
Ease of Insertion was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Ease of putting the lenses on your eyes " with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-Week Follow-up
Ease of Removal (Phase II)
Time Frame: 1-Week Follow-up
Ease of Removal was assessed using the individual questionnaire item "how would you rate the study contact lenses on: Ease of taking the lenses off your eyes" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
1-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.
July 12, 2021

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.
October 25, 2021

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.
October 25, 2021

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).
July 9, 2021

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.
July 9, 2021

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.
July 20, 2021

Study Record Updates

Last Update Posted (Estimate)

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.
December 22, 2022

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.
November 30, 2022

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.
November 1, 2022

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-6456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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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