Evaluation of Deposits on Contact Lenses Worn Extended Wear

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: balafilcon A contact lens (PureVision); Device: etafilcon A contact lens (Acuvue2)

• Registration Number: NCT00725530
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-09-25
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Results First Posted: 2012-08-22
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A / balafilcon A	balafilcon A contact lens (PureVision)	Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
balafilcon A / etafilcon A	balafilcon A contact lens (PureVision)	Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
balafilcon A / etafilcon A	etafilcon A contact lens (Acuvue2)	Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
etafilcon A / balafilcon A	etafilcon A contact lens (Acuvue2)	Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Primary Outcome Measures

Name	Time	Method
Front Surface Lens Deposits	7 days	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).

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States