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OpenTrials
Completed

NCT Number: NCT00725153

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.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balafilcon A contact lenses (PureVision)

Device

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Other names: PureVision

Etafilcon A contact lenses (Acuvue2)

Device

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Other names: Acuvue2

Primary outcomes

  1. Front Surface Lens Deposits

    Time frame: 10 hours

    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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2008
Registry last updated
Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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