Clinical Biocompatibility Evaluation of Contact Lens Coatings

Study Overview
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Brief Summary
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The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Detailed Description
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In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Official Title
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Clinical Biocompatibility Evaluation of Contact Lens Coatings

Conditions
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Refractive Errors, Ametropia

Intervention / Treatment
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* Device: Contact lens with investigational coating 1
* Device: Balafilcon A contact lens
* Device: OPTI-FREE® RepleniSH® MPDS
* Device: Contact lens with investigational coating 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and must sign an Informed Consent; Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; Manifest cylinder less than or equal to 1.50 diopter (D) in each eye; Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye; VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear; Any use of systemic or ocular medications for which contact lens wear could be contraindicated; History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye; Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; Current or history of pathologically dry eye in either eye that would preclude contact lens wear; Current or history of herpetic keratitis in either eye; Eye injury in either eye within 12 weeks immediately prior to enrollment; History of intolerance or hypersensitivity to any component of the study lenses or solutions; Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; Other protocol-specified exclusion criteria may apply.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test 1/Control 1, then Control 2/Test 2<br>Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. | Device: Contact lens with investigational coating 1<br>* Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)<br>* Other names: Test 1;Device: Balafilcon A contact lens<br>* Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS<br>* Other names: Control 2;Device: OPTI-FREE® RepleniSH® MPDS<br>* Multipurpose contact lens solution<br>Device: Contact lens with investigational coating 2<br>* Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS<br>* Other names: Test 2;|
| Other: Test 2/Control 2, then Control 1/Test 1<br>Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. | Device: Contact lens with investigational coating 1<br>* Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)<br>* Other names: Test 1;Device: Balafilcon A contact lens<br>* Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS<br>* Other names: Control 2;Device: OPTI-FREE® RepleniSH® MPDS<br>* Multipurpose contact lens solution<br>Device: Contact lens with investigational coating 2<br>* Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS<br>* Other names: Test 2;|
| Other: Control 1/Test 1, then Test 2/Control 2<br>Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. | Device: Contact lens with investigational coating 1<br>* Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)<br>* Other names: Test 1;Device: Balafilcon A contact lens<br>* Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS<br>* Other names: Control 2;Device: OPTI-FREE® RepleniSH® MPDS<br>* Multipurpose contact lens solution<br>Device: Contact lens with investigational coating 2<br>* Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS<br>* Other names: Test 2;|
| Other: Control 2/Test 2, then Test 1/Control 1<br>Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. | Device: Contact lens with investigational coating 1<br>* Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)<br>* Other names: Test 1;Device: Balafilcon A contact lens<br>* Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS<br>* Other names: Control 2;Device: OPTI-FREE® RepleniSH® MPDS<br>* Multipurpose contact lens solution<br>Device: Contact lens with investigational coating 2<br>* Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS<br>* Other names: Test 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Percent Area of Solution-related Corneal Staining | Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting. | Day 1 after 2 hours of wear, each product |