Clinical Performance Comparison of Two Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical performance of two contact lenses.

Official Title
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Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: senofilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existing daily soft lens wearer. Require a distance visual correction in both eyes. Have a contact lens spherical distance refraction between -1.00D and -6.00D. Have refractive astigmatism less than or equal to 1.00D in both eyes. Achieve 20/30 or better corrected distance acuity. Have normal eyes with no evidence of abnormality or disease. Exclusion Criteria: Requires presbyopic correction. Requires ocular medications. Grade 3 or 4 ocular abnormalities. Grade 3 corneal staining in more than one region. Has had refractive surgery. Any other injury or ocular surgery within 8 weeks prior to study enrollment. Has abnormal lacrimal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Has keratoconus or other corneal irregularity. Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks. Wears habitual contact lenses that are toric, multifocal or worn extended wear. Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear. Diabetic. Infectious or immunosuppressive disease. History of chronic eye disease (e.g glaucoma or age related macular degeneration). Pregnancy, lactation or planning pregnancy at time of enrollment. Participation in any concurrent clinical trial or in another trial in the last 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A both eyes<br>soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen. | Device: senofilcon A<br>* soft contact lens, 2-week replacement indicated<br>|
| Active Comparator: lotrafilcon B both eyes<br>soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen | Device: lotrafilcon B<br>* soft contact lens with a 4-week replacement indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Corneal Staining | The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe. | 2 weeks | 
| Visual Acuity | Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 2 weeks | 
| Overall Comfort | After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 2 weeks | 
| Overall Comfort | After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limbal Redness | The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | 2 weeks | 
| Bulbar Redness | The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | 2 weeks | 
| Symptoms of Dryness | Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None | 2 weeks |