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Clinical Evaluation of the Long‑Term Effects of Contact Lens Care Systems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00813761
First Posted: December 23, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
December 17, 2008
December 23, 2008
October 24, 2011
November 24, 2011
July 11, 2017
September 1, 2008
August 1, 2009   (Final data collection date for primary outcome measure)
  • Average Daily Wear Time [ Time Frame: 24 weeks ]
    Average hours per day that contact lens were worn.
  • Average Daily Comfortable Wear Time [ Time Frame: 24 weeks ]
    Average hours per day that contact lens were worn comfortably.
  • Lens Comfort [ Time Frame: 24 weeks ]
    Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
  • Frequency of Eye Discomfort [ Time Frame: 24 weeks ]
    Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
  • Frequency of Daily Lens Dryness [ Time Frame: 24 weeks ]
    Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
  • Frequency of Eye Burning/Stinging [ Time Frame: 24 weeks ]
    Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
  • Frequency of Itching [ Time Frame: 24 weeks ]
    Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
  • Frequency of Tearing [ Time Frame: 24 weeks ]
    Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
  • Average Corneal Fluorescein Type Staining [ Time Frame: 24 weeks ]
    staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
  • Average Corneal Fluorescein Staining Area [ Time Frame: 24 weeks ]
    corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
  • Limbal Redness [ Time Frame: 24 weeks ]
    Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
  • Bulbar Redness [ Time Frame: 24 weeks ]
    Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
  • Lower Tarsal Redness [ Time Frame: 24 weeks ]
    Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
  • Upper Tarsal Redness [ Time Frame: 24 weeks ]
    Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
  • Tarsal Roughness [ Time Frame: 24 weeks ]
    The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
  • subjective comfort [ Time Frame: at the following visits: 2 week, 1 month, 3 month, 6 month ]
  • biomicroscopy [ Time Frame: at the following visits: 2 week, 1 month, 3 month, 6 month ]
Complete list of historical versions of study NCT00813761 on ClinicalTrials.gov Archive Site
  • Intensity of Physiological Outcomes [ Time Frame: 24 weeks ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5.
  • Wearing Time and Comfortable Wearing Time [ Time Frame: 24 weeks ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.
  • Physiological Responses [ Time Frame: 24 weeks ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of the Long‑Term Effects of Contact Lens Care Systems
Not Provided
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myopia
  • Device: O2Optix contact lens
    control contact lens to be worn daily for approximately 7 months for entire length of study.
  • Device: Proclear contact lens
    control contact lens to be worn for entire length of study.
  • Device: ReNu MultiPlus Multi-Purpose Solution
    lens solution for overnight lens disinfection
  • Device: Clear Care Cleaning and Disinfecting Solution
    lens solution for overnight lens disinfection
  • 02Optix CL and ReNu MPS with SICS
    O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
    Interventions:
    • Device: O2Optix contact lens
    • Device: ReNu MultiPlus Multi-Purpose Solution
  • Proclear CL and ReNu MPS with SICS
    Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
    Interventions:
    • Device: Proclear contact lens
    • Device: ReNu MultiPlus Multi-Purpose Solution
  • 02Optix CL and Clear Care LCS with SICS
    O2Optix contact lens and Clear Care lens care solution subject
    Interventions:
    • Device: O2Optix contact lens
    • Device: Clear Care Cleaning and Disinfecting Solution
  • Proclear CL and Clear Care LCS with SICS
    Proclear contact lens and Clear Care lens care solution
    Interventions:
    • Device: Proclear contact lens
    • Device: Clear Care Cleaning and Disinfecting Solution
  • 02Optix CL and ReNu MPS without SICS
    O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
    Interventions:
    • Device: O2Optix contact lens
    • Device: ReNu MultiPlus Multi-Purpose Solution
  • Proclear CL and ReNu MPS without SICS
    Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
    Interventions:
    • Device: Proclear contact lens
    • Device: ReNu MultiPlus Multi-Purpose Solution
  • 02Optix CL and Clear Care LCS without SICS
    O2Optix contact lens and Clear Care lens care solution
    Interventions:
    • Device: O2Optix contact lens
    • Device: Clear Care Cleaning and Disinfecting Solution
  • Proclear CL and Clear Care LCS without SICS
    Proclear contact lens and Clear Care lens care solution
    Interventions:
    • Device: Proclear contact lens
    • Device: Clear Care Cleaning and Disinfecting Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
473
August 1, 2009
August 1, 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be at least 18 years old.
  • Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
  • Require a visual correction in both eyes (monovision allowed but not monofit).
  • Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
  • Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
  • Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Worn lenses on an extended wear basis in the last 3 months.
  • Diabetic.
  • Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
  • Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
  • Abnormal lacrimal secretions.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT00813761
CR-4522
No
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
June 2017

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