Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

June 14, 2017 updated by: Johnson & Johnson Vision Care, Inc.
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

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.
72

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.
  • Phase 4

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
    • Florida
      • Jacksonville, Florida, United States, 32205
      • Jacksonville, Florida, United States, 32256

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 45 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 be no less than 18 and no more than 45 years of age with no presbyopic add.
  • The subject must be willing and able to adhere to the instructions set out in the protocol.
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must be willing to wear the study contact lenses up to 14 hours/day.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
  • The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
  • The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
  • The subject must require a visual correction in both eyes (no monofit or monovision allowed).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

  • Current 1-DAY ACUVUE® TruEye® wearers
  • Anisometropia of 1.00 D or greater
  • Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
  • Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
  • 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.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Pregnancy or lactation
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Employee of investigational clinic (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: Other
  • 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: Test/Control - Phase 1
Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner.
Device: Contact Lenses with 8.5 BC
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Device: Contact Lenses with 9.0 BC
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Experimental: Control/Test - Phase 1
Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner.
Device: Contact Lenses with 8.5 BC
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Device: Contact Lenses with 9.0 BC
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Experimental: Test/Control - Phase 2
During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner.
Device: Contact Lenses with 8.5 BC
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Device: Contact Lenses with 9.0 BC
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Experimental: Control/Test - Phase 2
During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner.
Device: Contact Lenses with 8.5 BC
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses
Device: Contact Lenses with 9.0 BC
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other Names:
  • Marketed Daily Disposable Soft Contact Lenses

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
Correlation Between Subjective CLUE Comfort and Keratometry
Time Frame: 3-day follow-up
CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
3-day follow-up
Correlation Between Subjective CLUE Comfort and Corneal Diameter
Time Frame: 3-day follow-up
Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
3-day 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 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.
July 1, 2015

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.
July 1, 2015

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).
August 28, 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.
August 31, 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 1, 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 11, 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.
June 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.
June 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-5730

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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