Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 473
- Primary Endpoint
- Lens Comfort
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Lens Comfort
Time Frame: 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
Time Frame: 24 weeks
Average hours per day that contact lens were worn comfortably.
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.
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
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 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 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%.
Average Daily Wear Time
Time Frame: 24 weeks
Average hours per day that contact lens were worn.
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.
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
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.
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
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
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
Secondary Outcomes
- Intensity of Physiological Outcomes(24 weeks)
- Wearing Time and Comfortable Wearing Time(24 weeks)
- Physiological Responses(24 weeks)