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Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01155323
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : October 4, 2011
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 1, 2010
Results First Submitted Date  ICMJE August 29, 2011
Results First Posted Date  ICMJE October 4, 2011
Last Update Posted Date June 19, 2018
Actual Study Start Date  ICMJE March 1, 2010
Actual Primary Completion Date June 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • Subjective Rating of Comfort [ Time Frame: after 1 week of lens wear ]
    This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
  • Vision Quality [ Time Frame: after 1 week of lens wear ]
    This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
  • Subjective Rating of Handling [ Time Frame: after 1 week of lens wear ]
    This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
  • Corneal Staining [ Time Frame: after 1 week of lens wear ]
    Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
  • Subjective Rating of Quality Perceptions [ Time Frame: after 1 week of lens wear ]
    This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
  • Limbal Hyperemia [ Time Frame: after 1 week of wear ]
    This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
  • Subjective rating of lens comfort [ Time Frame: after 2 weeks of use ]
  • Subjective rating of lens handling [ Time Frame: after 2 weeks of use ]
  • Subjective rating of vision quality [ Time Frame: after 2 weeks of use ]
  • Signs of limbal hyperemia [ Time Frame: after 2 weeks of use ]
  • Signs of corneal staining [ Time Frame: after 2 weeks of use ]
  • Investigator assessment of lens fit [ Time Frame: after 2 weeks of use ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
  • Subject reported contact lens wearing time [ Time Frame: after 2 weeks of use ]
  • Subject reported symptoms [ Time Frame: after 2 weeks of use ]
  • Visual acuity [ Time Frame: after 2 weeks of use ]
  • Investigator assessment of tear film characteristics [ Time Frame: after 2 weeks of use ]
  • Investigator reported slit lamp findings [ Time Frame: after 2 weeks of use ]
  • Subject reported number of lens breakages [ Time Frame: after 2 weeks of use ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
Official Title  ICMJE Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
Brief Summary This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: etafilcon A
    1-day soft contact lens
  • Device: omafilcon A
    1-day soft contact lens
Study Arms  ICMJE
  • Active Comparator: etafilcon A/omafilcon A
    etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily
    Interventions:
    • Device: etafilcon A
    • Device: omafilcon A
  • Active Comparator: omafilcon A/etafilcon A
    omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.
    Interventions:
    • Device: etafilcon A
    • Device: omafilcon A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
118
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2010)
120
Actual Study Completion Date  ICMJE June 1, 2010
Actual Primary Completion Date June 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age and no more than 39 years of age
  • Existing soft contact lens wearers
  • Willing to signed a written Informed Consent.
  • Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
  • Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
  • Have an Astigmatism of 1.00D or less in both eyes.
  • Require a visual correction in both eyes.
  • Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
  • Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria:

  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Clinically significant corneal staining (Grade 3 in more than one region).
  • Keratoconus or other corneal irregularity.
  • Abnormal lachrymal secretions.
  • Extended wear of contact lenses last 3 months.
  • Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
  • Refractive surgery.
  • Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Require concurrent ocular medication
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
  • Diabetes.
  • Pregnant, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial or in last 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155323
Other Study ID Numbers  ICMJE CR-0926
DISP-523 ( Other Identifier: Visioncare Research Ltd )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Vision Care, Inc.
Study Sponsor  ICMJE Johnson & Johnson Vision Care, Inc.
Collaborators  ICMJE
  • Johnson & Johnson K.K. Medical Company
  • Visioncare Research Ltd.
Investigators  ICMJE
Principal Investigator: Danny Sim, Diploma in Optometry Singapore Polytechnic
PRS Account Johnson & Johnson Vision Care, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP