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Corneal Staining Associated With Daily Disposable Beauty Contact Lenses

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01882465
First received: June 7, 2013
Last updated: October 5, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Refractive Error
Device: etafilcon A
Device: 2-HEMA, EGDMA Non-ionic
Device: hefilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Corneal Staining Associated With Daily Disposable Beauty Contact Lenses

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: 20 minutes and 7 hours post lens fitting ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: August 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black
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 Name: 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 Name: 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 Name: Ticon Cosmetic Daily Black

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882465

Locations
Hong Kong
Hong Kong Polytechnic University
Hong Hom, Kowloon, Hong Kong
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01882465     History of Changes
Other Study ID Numbers: CR-5360 
Study First Received: June 7, 2013
Results First Received: June 20, 2016
Last Updated: October 5, 2016
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on December 08, 2016