Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00813761
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : November 24, 2011
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Condition or disease Intervention/treatment Phase
Myopia Device: O2Optix contact lens Device: Proclear contact lens Device: ReNu MultiPlus Multi-Purpose Solution Device: Clear Care Cleaning and Disinfecting Solution Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 1, 2008
Actual Primary Completion Date : August 1, 2009
Actual Study Completion Date : August 1, 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
02Optix CL and ReNu MPS with SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
 Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.

Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS with SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
 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
02Optix CL and Clear Care LCS with SICS
O2Optix contact lens and Clear Care lens care solution subject
 Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.

Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS with SICS
Proclear contact lens and Clear Care lens care solution
 Device: Proclear contact lens
control contact lens to be worn for entire length of study.

Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
02Optix CL and ReNu MPS without SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
 Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.

Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS without SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
 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
02Optix CL and Clear Care LCS without SICS
O2Optix contact lens and Clear Care lens care solution
 Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.

Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS without SICS
Proclear contact lens and Clear Care lens care solution
 Device: Proclear contact lens
control contact lens to be worn for entire length of study.

Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Average Daily Wear Time [ Time Frame: 24 weeks ]
    Average hours per day that contact lens were worn.

  2. Average Daily Comfortable Wear Time [ Time Frame: 24 weeks ]
    Average hours per day that contact lens were worn comfortably.

  3. Lens Comfort [ Time Frame: 24 weeks ]
    Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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%.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813761


Locations
Layout table for location information
United States, Arkansas
North Little Rock, Arkansas, United States
United States, California
Campbell, California, United States
Cupertino, California, United States
Laguna Niguel, California, United States
Mission Viejo, California, United States
San Clemente, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Illinois
Bloomington, Illinois, United States
United States, Kansas
Neodesha, Kansas, United States
United States, Missouri
Raytown, Missouri, United States
Warrensburg, Missouri, United States
United States, New Jersey
Florence, New Jersey, United States
United States, Ohio
Chagrin Falls, Ohio, United States
Warren, Ohio, United States
United States, Pennsylvania
Kittanning, Pennsylvania, United States
Moon, Pennsylvania, United States
Nanticoke, Pennsylvania, United States
State College, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Dakota
Chamberlain, South Dakota, United States
United States, Tennessee
Bartlett, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Midlothian, Virginia, United States
Virginia Beach, Virginia, United States
United Kingdom
Aston Triangle, Birmingham, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00813761    
Other Study ID Numbers: CR-4522
First Posted: December 23, 2008    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: June 19, 2018
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions