Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

Study Overview
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Brief Summary
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The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Detailed Description
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The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Official Title
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Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

Conditions
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Ocular Comfort

Intervention / Treatment
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* Device: Lotrafilcon A test contact lens
* Device: Lotrafilcon A control contact lens
* Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age of consent and sign Informed Consent document. Normal binocularity. Be able to wear soft contact lenses. Willing to comply with the wear and study visit schedule. Spherical contact lens prescription within 0.50 diopter of the available lens powers. Spectacle cylinder less than or equal to 1.50 diopter. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator. Other protocol-defined 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon A test/lotrafilcon A control<br>Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. | Device: Lotrafilcon A test contact lens<br>* Silicone hydrogel single vision, soft contact lens with alternate parameters<br>Device: Lotrafilcon A control contact lens<br>* Silicone hydrogel single vision, soft contact lens<br>* Other names: Night&Day;Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)<br>* Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear<br>|
| Other: Lotrafilcon A control/lotrafilcon A test<br>Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. | Device: Lotrafilcon A test contact lens<br>* Silicone hydrogel single vision, soft contact lens with alternate parameters<br>Device: Lotrafilcon A control contact lens<br>* Silicone hydrogel single vision, soft contact lens<br>* Other names: Night&Day;Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)<br>* Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Comfort | Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses). | Day 2, Hour 10 |