Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel 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 three silicone hydrogel contact lenses over a 2 week period.

Conditions
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Myopia

Intervention / Treatment
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* Device: galyfilcon A, BC 8.30
* Device: lotrafilcon B, BC 8.60
* Device: comfilcon A, BC 8.60


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be no less than 18 and no more than 39 years of age. Sign Written Informed Consent and investigator to record this on Case Report Form. Be willing and able to adhere to the instructions set out in the protocol. Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month. No extended wear in the last 3 months. Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters. Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes. Achieve visual acuity of 6/9 (20/30) or better in each eye. Require a visual correction in both eyes (no monovision allowed). Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease. Exclusion Criteria: Requires concurrent ocular medication. Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. Clinically significant corneal staining Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters). Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study. Abnormal lacrimal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Diabetic. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)]. History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration). Pregnancy, lactating or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial or in last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Other: galyfilcon A<br>Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. | Device: galyfilcon A, BC 8.30<br>* galyfilcon A, BC 8.30 soft contact lens<br>|
| Other: lotrafilcon B<br>Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. | Device: lotrafilcon B, BC 8.60<br>* lotrafilcon B, BC 8.60 soft contact lens<br>|
| Other: comfilcon A<br>Subjects that were randomized to wear comfilcon A lens throughout the course of the study. | Device: comfilcon A, BC 8.60<br>* comfilcon A, BC 8.60 soft contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Subjective Comfort | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | after 2 weeks of contact lens wear | 
| Corneal Staining | Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated. | after 2 weeks of contact lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Subjective Lens Handling | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated. | after 2 weeks of contact lens wear |