Evaluation of Deposits on Contact Lenses Worn Daily Wear

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

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Balafilcon A contact lenses (PureVision); Device: Etafilcon A contact lenses (Acuvue2)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PureVision/Acuvue 2; 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); Commercially marketed, soft contact lenses worn bilaterally for 10 hours; Other Names: PureVision; Device: Etafilcon A contact lenses (Acuvue2); Commercially marketed, soft contact lenses worn bilaterally for 10 hours; Other Names: Acuvue2
Other: Acuvue 2/PureVision; 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); Commercially marketed, soft contact lenses worn bilaterally for 10 hours; Other Names: PureVision; Device: Etafilcon A contact lenses (Acuvue2); Commercially marketed, soft contact lenses worn bilaterally for 10 hours; 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 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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Myopia; Soft contact lenses; Contact lens deposits
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: MS-006