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

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01155323
First received: June 30, 2010
Last updated: August 16, 2013
Last verified: August 2013

June 30, 2010
August 16, 2013
March 2010
June 2010   (final data collection date for primary outcome measure)
  • Subjective Rating of Comfort [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Subjective rating of lens comfort [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Signs of limbal hyperemia [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Subjective rating of lens handling [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Subjective rating of vision quality [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Investigator assessment of lens fit [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Signs of corneal staining [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01155323 on ClinicalTrials.gov Archive Site
Not Provided
  • Subject reported contact lens wearing time [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Subject reported symptoms [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Investigator assessment of tear film characteristics [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Investigator reported slit lamp findings [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
  • Subject reported number of lens breakages [ Time Frame: after 2 weeks of use ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • Device: etafilcon A
    1-day soft contact lens
  • Device: omafilcon A
    1-day soft contact lens
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
Not Provided
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01155323
CR-0926, DISP-523
Not Provided
Vistakon
Vistakon
  • Johnson & Johnson K.K. Medical Company
  • Visioncare Research Ltd.
Principal Investigator: Danny Sim, Diploma in Optometry Singapore Polytechnic
Vistakon
August 2013

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