Evaluation of Deposits on Contact Lenses Worn Extended Wear

Alcon Research54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

balafilcon A contact lens (PureVision)DEVICE

Commercially marketed, silicone hydrogel contact lens

etafilcon A contact lens (Acuvue2)DEVICE

Commercially marketed, hydrogel contact lens

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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 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).

Time frame: 7 days

Data from ClinicalTrials.gov

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