Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

Study Overview
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Brief Summary
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The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.

Conditions
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Myopia, Dry Eye

Intervention / Treatment
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* Device: lotrafilcon A contact lenses
* Device: comfilcon A contact lenses
* Other: Glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70. History of end-of-day or low-humidity dryness with contact lenses. Healthy eyes. Best-corrected visual acuity of 20/50 or better for each eye. Usable pair of eye glasses. Willing and able to attend required study visits. Sign informed consent. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Ocular or systemic allergies or diseases which might interfere with contact lens wear. Clinically significant ocular findings which would contraindicate contact lens wear. Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days. Participation in another clinical study currently or within 30 days of study entry. Spectacle astigmatism of >1.00 diopter. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lotrafilcon A / Comfilcon A / Glasses<br>Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. | Device: lotrafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Air Optix Night and Day AQUA;Device: comfilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Biofinity;Other: Glasses<br>* Glasses per habitual prescription<br>|
| Active Comparator: comfilcon A / glasses / lotrafilcon A<br>Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. | Device: lotrafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Air Optix Night and Day AQUA;Device: comfilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Biofinity;Other: Glasses<br>* Glasses per habitual prescription<br>|
| Active Comparator: glasses / lotrafilcon A / comfilcon A<br>Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. | Device: lotrafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Air Optix Night and Day AQUA;Device: comfilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.<br>* Other names: Biofinity;Other: Glasses<br>* Glasses per habitual prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Osmolarity | The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity. | 90 minutes | 
| Ocular Comfort | Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort. | 90 minutes |