Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
- Conditions
- Myopia
- Interventions
- Device: Proclear contact lensDevice: O2Optix contact lensDevice: Clear Care Cleaning and Disinfecting SolutionDevice: ReNu MultiPlus Multi-Purpose Solution
- Registration Number
- NCT00813761
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proclear CL and ReNu MPS with SICS Proclear contact lens Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution Proclear CL and ReNu MPS without SICS Proclear contact lens Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution Proclear CL and Clear Care LCS without SICS Proclear contact lens Proclear contact lens and Clear Care lens care solution Proclear CL and Clear Care LCS without SICS Clear Care Cleaning and Disinfecting Solution Proclear contact lens and Clear Care lens care solution 02Optix CL and ReNu MPS with SICS ReNu MultiPlus Multi-Purpose Solution O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution 02Optix CL and Clear Care LCS with SICS O2Optix contact lens O2Optix contact lens and Clear Care lens care solution subject 02Optix CL and Clear Care LCS with SICS Clear Care Cleaning and Disinfecting Solution O2Optix contact lens and Clear Care lens care solution subject Proclear CL and Clear Care LCS with SICS Proclear contact lens Proclear contact lens and Clear Care lens care solution Proclear CL and Clear Care LCS with SICS Clear Care Cleaning and Disinfecting Solution Proclear contact lens and Clear Care lens care solution 02Optix CL and ReNu MPS with SICS O2Optix contact lens O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution Proclear CL and ReNu MPS with SICS ReNu MultiPlus Multi-Purpose Solution Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution 02Optix CL and ReNu MPS without SICS ReNu MultiPlus Multi-Purpose Solution O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution Proclear CL and ReNu MPS without SICS ReNu MultiPlus Multi-Purpose Solution Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution 02Optix CL and Clear Care LCS without SICS O2Optix contact lens O2Optix contact lens and Clear Care lens care solution 02Optix CL and ReNu MPS without SICS O2Optix contact lens O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution 02Optix CL and Clear Care LCS without SICS Clear Care Cleaning and Disinfecting Solution O2Optix contact lens and Clear Care lens care solution
- Primary Outcome Measures
Name Time Method Lens Comfort 24 weeks Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Average Daily Comfortable Wear Time 24 weeks Average hours per day that contact lens were worn comfortably.
Frequency of Eye Discomfort 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.
Average Daily Wear Time 24 weeks Average hours per day that contact lens were worn.
Frequency of Eye Burning/Stinging 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.
Tarsal Roughness 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
Average Corneal Fluorescein Type Staining 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.
Bulbar Redness 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
Upper Tarsal Redness 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
Frequency of Daily Lens Dryness 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 Itching 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 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 Staining Area 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 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
Lower Tarsal Redness 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
- Secondary Outcome Measures
Name Time Method Intensity of Physiological Outcomes 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 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 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).