Corneal Staining Associated With Daily Disposable Beauty Contact Lenses

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring pattern to the contact lens. The purpose of this investigation is to determine if corneal staining increase is dependent upon the lens pigment location.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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.
35

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

  • Hong Kong
    • Kowloon
      • Hong Hom, Kowloon, Hong Kong
        • Hong Kong Polytechnic University

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Fluency in English and ability to read and understand written English.
  3. The subject must be able and willing to adhere to the instructions set forth in this clinical protocol.
  4. The subject must be between 18 and 35 years of age.
  5. The subject must be an adapted (minimum of 4 week history of daily wear prior to the baseline study visit) soft contact lens wearer in both eyes.
  6. The subject must be East or Southeast Asia descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. by self-report.
  7. The subject must come in with a current (no more than 12 month old) spectacle or contact lens prescription as indicated. (NB: Emmetropic subjects who wear contact lenses for enhancement purposes only will also require a current contact lens prescription).
  8. The subject's vertex corrected spherical equivalent distance refraction must be in the range of PLANO to -6.00 Diopter (D) in each eye.
  9. The subject must have best corrected visual acuity on +0.24 logMAR (equivalent to 20/30 (-2)) or better in each eye.
  10. The subject must own a wearable pair of spectacles (as indicated by current prescription) and wear them to all visits including the screening visit as required for vision correction. They must be willing to wear their spectacles during the 24 hour washout period leading up to each treatment visit (NB: Emmetropic subjects who do not own spectacles must agree to no lens wear on all visit days including the screening visit).
  11. The subject must have normal eye (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

  1. Are currently pregnant or lactating, determined by self-report (subjects who become pregnant during the study will be discontinued).
  2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
  4. Use any topical medication such as eye drops or ointment.
  5. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  6. Had any previous, or have planned, ocular or intraocular surgery (e.g., cataract surgery, radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK).
  7. Have any grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
  8. Have any known hypersensitivity or allergic reaction to contact lenses (as assessed by ocular history).
  9. Have any ocular infection.
  10. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  11. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  12. Have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  13. Currently wear their contact lenes on an extended wear basis.
  14. Is an employee of the investigational clinic (e.g., Investigator, Coordinator, Technician).
  15. Currently wears toric or multifocal contact lenses. If the subject wears soft contact lenses for monovision, they must be willing to wear distance only correction in both eyes for the 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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

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.
OTHER: etafilcon A/2-HEMA, EGDMA/hefilcon A
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black
OTHER: etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black
OTHER: 2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black
OTHER: 2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black
OTHER: hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black
OTHER: hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic
Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Device: etafilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • 1-Day Acuvue DEFINE (Vivid)
Device: 2-HEMA, EGDMA Non-ionic
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • SEED Eye Coffret 1-Day UV Rich Make
Device: hefilcon A
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
Other Names:
  • Ticon Cosmetic Daily Black

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
Time Frame: 20 minutes and 7 hours post lens fitting
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.
20 minutes and 7 hours post lens fitting

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

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.
August 1, 2013

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.
August 1, 2013

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.
August 1, 2013

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).
June 7, 2013

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.
June 17, 2013

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.
June 20, 2013

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.
June 19, 2018

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 18, 2018

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, 2016

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.
  • CR-5360

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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