Evaluation of Deposits on Contact Lenses Worn Extended Wear

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: balafilcon A contact lens (PureVision)
* Device: etafilcon A contact lens (Acuvue2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses. Successfully wearing hydrogel or silicone hydrogel contact lenses. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Evidence or history of ocular conditions as prescribed in the protocol. One functional eye or a monofit lens. Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol. Use of concomitant topical ocular prescription or over-the-counter ocular medications. History of seasonal allergies with significant ocular side effects. 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: balafilcon A / etafilcon A<br>Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. | Device: balafilcon A contact lens (PureVision)<br>* Commercially marketed, silicone hydrogel contact lens<br>* Other names: PureVision;Device: etafilcon A contact lens (Acuvue2)<br>* Commercially marketed, hydrogel contact lens<br>* Other names: Acuvue2;|
| Active Comparator: etafilcon A / balafilcon A<br>Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. | Device: balafilcon A contact lens (PureVision)<br>* Commercially marketed, silicone hydrogel contact lens<br>* Other names: PureVision;Device: etafilcon A contact lens (Acuvue2)<br>* Commercially marketed, hydrogel contact lens<br>* Other names: Acuvue2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Front Surface Lens Deposits | Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both). | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lens deposits, Soft contact lens wearers