Clinical Comparison of Silicone Hydrogel Monthly Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.

Official Title
-----------------
One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors

Conditions
-----------------
Refractive Error

Intervention / Treatment
-----------------
* Device: Lotrafilcon B contact lenses
* Device: Senofilcon C contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign Informed Consent; Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1; Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1; Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses; Screening lenses worn 10 hours exhibiting high lipid uptake. Exclusion Criteria: Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months; Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months; Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current) History of herpetic keratitis, corneal surgery, or irregular cornea; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; Abnormal ocular conditions or findings, as specified in the protocol; Known pregnancy and lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon B, then senofilcon C<br>Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. | Device: Lotrafilcon B contact lenses<br>* Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking<br>* Other names: AIR OPTIX® plus HydraGlyde;Device: Senofilcon C contact lenses<br>* Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking<br>* Other names: ACUVUE® VITA®;|
| Other: Senofilcon C, then lotrafilcon B<br>Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. | Device: Lotrafilcon B contact lenses<br>* Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking<br>* Other names: AIR OPTIX® plus HydraGlyde;Device: Senofilcon C contact lenses<br>* Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking<br>* Other names: ACUVUE® VITA®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis. | Day 30 after 10 hours of wear, each product | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, lipids, deposits