Mucin Balls and Corneal Inflammation Events

Study Overview
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Brief Summary
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The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.

Conditions
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Corneal Inflammation, Corneal Infiltrative Events

Intervention / Treatment
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* Device: lotrafilcon A
* Device: comfilcon A
* Device: balafilcon A
* Other: etafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE). Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded. Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively. Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency. Correctable vision to 20/30 or better at distance with dispensed contact lenses. Exclusion Criteria: Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months. Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear. Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation. Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery. Use of any ocular medications in the last 2 weeks. Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Currently pregnant or lactating. Smoker Swimming routine of more than twice per month.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lotrafilcon A, comfilcon A<br>All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I. | Device: lotrafilcon A<br>* To be used during run-in phase only.<br>Device: comfilcon A<br>* To be assigned at randomization at phase 2 only.<br>Other: etafilcon A<br>* Assigned to Neophytes during Phase I for a 2-week period<br>|
| Active Comparator: lotrafilcon A, balafilcon A<br>All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I. | Device: lotrafilcon A<br>* To be used during run-in phase only.<br>Device: balafilcon A<br>* To be assigned at randomization during phase 2 only.<br>Other: etafilcon A<br>* Assigned to Neophytes during Phase I for a 2-week period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Infiltrate Events - Phase I | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | 1-Month Follow-up | 
| Corneal Infiltrate Event- Phase II | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | 12-Month Follow-up |