Evaluation of Deposits on Contact Lenses Worn Daily Wear

Study Overview
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Brief Summary
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The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Balafilcon A contact lenses (PureVision)
* Device: Etafilcon A contact lenses (Acuvue2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years 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 prior to enrollment in the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye. One functional eye or a monofit lens. Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis. Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol. Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications. History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear. 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: PureVision/Acuvue 2<br>PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each. | Device: Balafilcon A contact lenses (PureVision)<br>* Commercially marketed, soft contact lenses worn bilaterally for 10 hours<br>* Other names: PureVision;Device: Etafilcon A contact lenses (Acuvue2)<br>* Commercially marketed, soft contact lenses worn bilaterally for 10 hours<br>* Other names: Acuvue2;|
| Other: Acuvue 2/PureVision<br>Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each. | Device: Balafilcon A contact lenses (PureVision)<br>* Commercially marketed, soft contact lenses worn bilaterally for 10 hours<br>* Other names: PureVision;Device: Etafilcon A contact lenses (Acuvue2)<br>* Commercially marketed, soft contact lenses worn bilaterally for 10 hours<br>* Other names: Acuvue2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Front Surface Lens Deposits | Film and discrete deposits were assessed with a slit-lamp after 10 hours of 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). | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens deposits, Soft contact lenses, Myopia