Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

Detailed Description
-----------------
This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Official Title
-----------------
Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Conditions
-----------------
Myopia, Astigmatism, Refractive Error

Intervention / Treatment
-----------------
* Device: Lotrafilcon B contact lenses
* Device: Senofilcon A contact lenses
* Device: OPTI-FREE® PUREMOIST® MPDS
* Device: BIOTRUE®
* Device: Balafilcon A contact lenses
* Device: ReNu® Multiplus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Read and understand the Participant Information Sheet; Read, sign, and date the Informed Consent; Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality; Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria; Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule; Best corrected visual acuity of 6/9 or better in each eye; Normal eyes with the exception of the need for visual correction; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used; Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses); Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects; Systemic disease which might interfere with contact lens wear or produce dry eye side effects; Systemic or ocular allergies which might interfere with contact lens wear; Ocular disease which might interfere with contact lens wear; Active ocular infection; Use of any concomitant topical ocular medications during the study period; Previous ocular surgery; Pregnant, planning to become pregnant, or lactating at the time of enrollment; Participation in an investigational drug or device study within 30 days of entering this study; Other protocol-defined exclusion criteria may apply.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air Optix Aqua<br>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each | Device: Lotrafilcon B contact lenses<br>* Silicone hydrogel contact lenses, Phase 2<br>* Other names: AOA;Device: OPTI-FREE® PUREMOIST® MPDS<br>* Contact lens care system, Phase 2<br>* Other names: OFPM;Device: BIOTRUE®<br>* Contact lens care system, Phase 2<br>Device: Balafilcon A contact lenses<br>* Silicone hydrogel contact lenses worn for 30 days, Phase 1<br>* Other names: PureVision;Device: ReNu® Multiplus®<br>* Contact lens care system used for 30 days, Phase 1<br>|
| Active Comparator: Acuvue Oasys<br>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each | Device: Senofilcon A contact lenses<br>* Silicone hydrogel contact lenses, Phase 2<br>* Other names: AVO;Device: OPTI-FREE® PUREMOIST® MPDS<br>* Contact lens care system, Phase 2<br>* Other names: OFPM;Device: BIOTRUE®<br>* Contact lens care system, Phase 2<br>Device: Balafilcon A contact lenses<br>* Silicone hydrogel contact lenses worn for 30 days, Phase 1<br>* Other names: PureVision;Device: ReNu® Multiplus®<br>* Contact lens care system used for 30 days, Phase 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex-Vivo Total Lipid Uptake Per Lens | The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean. | Day 30 | 
| LogMAR Time-Controlled Visual Acuity (TCVA) | Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20. | Day 30 | 
| Overall Comfort Measured With Visual Analog Scale (VAS) | The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | Day 30 | 
| Overall Dryness Measured With Visual Analog Scale (VAS) | The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | Day 30 | 
| Average Exposure Speed | Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean. | Day 30 | 
| Minimum Protected Area | Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean. | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, contact lens solution, myopia, astigmatism