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OpenTrials
Completed

NCT Number: NCT00775021

A Clinical Comparison of Two Daily Disposable Contact Lenses.

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otometry Technology Group, Ltd.

London, SW1E 6AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 years to 45 years
  • Current daily soft contact lens as habitual optical correction:
  • Refraction:
  • Best sphere (corrected for back vertex distance) -1.00 to -6.00D
  • Cylinder 0.00 to - 0.75D
  • Best spectacle corrected visual acuity of 6/9 or better in each eye
  • Willingness to adhere to the instructions set in the clinical protocol
  • Signature of the subject on the informed consent form

Exclusion criteria

  • Systemic or ocular allergies which might interfere with contact lens wear
  • Systemic disease which might interfere with contact lens wear
  • Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
  • Use of medication which might interfere with contact lens wear
  • Active ocular infection
  • Use of ocular medication
  • Significant ocular anomaly
  • Presence of two or more corneal scars in either eye
  • Pregnancy or lactation
  • Any medical condition that might be prejudicial to the study
  • Participated in any other clinical studies in the past month
  • Currently wears monovision

Treatment and study plan

etafilcon A

Device

Contact Lens

Nelfilcon A

Device

Contact Lens

Primary outcomes

  1. Overall Comfort

    Time frame: 1 week

    Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary outcomes

  1. Inferior Region Corneal Staining

    Time frame: 1 week

    The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)

  2. End of the Day Comfort

    Time frame: 1 week

    Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

  3. Initial Comfort

    Time frame: 1 Week

    Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

  4. Overall Lens Handling

    Time frame: 1 week

    Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2008
Registry last updated
Jun 19, 2018

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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