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

Study Overview
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Brief Summary
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The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Conditions
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Myopia

Intervention / Treatment
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* Device: O2Optix contact lens
* Device: Proclear contact lens
* Device: ReNu MultiPlus Multi-Purpose Solution
* Device: Clear Care Cleaning and Disinfecting Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 02Optix CL and ReNu MPS with SICS<br>O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution | Device: O2Optix contact lens<br>* control contact lens to be worn daily for approximately 7 months for entire length of study.<br>Device: ReNu MultiPlus Multi-Purpose Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: Proclear CL and ReNu MPS with SICS<br>Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution | Device: Proclear contact lens<br>* control contact lens to be worn for entire length of study.<br>Device: ReNu MultiPlus Multi-Purpose Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: 02Optix CL and Clear Care LCS with SICS<br>O2Optix contact lens and Clear Care lens care solution subject | Device: O2Optix contact lens<br>* control contact lens to be worn daily for approximately 7 months for entire length of study.<br>Device: Clear Care Cleaning and Disinfecting Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: Proclear CL and Clear Care LCS with SICS<br>Proclear contact lens and Clear Care lens care solution | Device: Proclear contact lens<br>* control contact lens to be worn for entire length of study.<br>Device: Clear Care Cleaning and Disinfecting Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: 02Optix CL and ReNu MPS without SICS<br>O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution | Device: O2Optix contact lens<br>* control contact lens to be worn daily for approximately 7 months for entire length of study.<br>Device: ReNu MultiPlus Multi-Purpose Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: Proclear CL and ReNu MPS without SICS<br>Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution | Device: Proclear contact lens<br>* control contact lens to be worn for entire length of study.<br>Device: ReNu MultiPlus Multi-Purpose Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: 02Optix CL and Clear Care LCS without SICS<br>O2Optix contact lens and Clear Care lens care solution | Device: O2Optix contact lens<br>* control contact lens to be worn daily for approximately 7 months for entire length of study.<br>Device: Clear Care Cleaning and Disinfecting Solution<br>* lens solution for overnight lens disinfection<br>|
| Other: Proclear CL and Clear Care LCS without SICS<br>Proclear contact lens and Clear Care lens care solution | Device: Proclear contact lens<br>* control contact lens to be worn for entire length of study.<br>Device: Clear Care Cleaning and Disinfecting Solution<br>* lens solution for overnight lens disinfection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Wear Time | Average hours per day that contact lens were worn. | 24 weeks | 
| Average Daily Comfortable Wear Time | Average hours per day that contact lens were worn comfortably. | 24 weeks | 
| Lens Comfort | Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent. | 24 weeks | 
| Frequency of Eye Discomfort | 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. | 24 weeks | 
| Frequency of Daily Lens Dryness | 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. | 24 weeks | 
| Frequency of Eye Burning/Stinging | 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. | 24 weeks | 
| Frequency of Itching | 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. | 24 weeks | 
| Frequency of Tearing | 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. | 24 weeks | 
| Average Corneal Fluorescein Type Staining | 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. | 24 weeks | 
| Average Corneal Fluorescein Staining Area | 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%. | 24 weeks | 
| Limbal Redness | 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 | 24 weeks | 
| Bulbar Redness | 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 | 24 weeks | 
| Lower Tarsal Redness | 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 | 24 weeks | 
| Upper Tarsal Redness | 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 | 24 weeks | 
| Tarsal Roughness | 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 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of Physiological Outcomes | 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. | 24 weeks | 
| Wearing Time and Comfortable Wearing Time | 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. | 24 weeks | 
| Physiological Responses | 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). | 24 weeks |