Evaluation of Deposits on Contact Lenses Worn Daily Wear

N/ACompletedNCT00725153

Alcon Research55 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Refractive Error

Interventions

Balafilcon A contact lenses (PureVision)DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Etafilcon A contact lenses (Acuvue2)DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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).

Time frame: 10 hours

Data from ClinicalTrials.gov

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