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A Clinical Comparison of Two Daily Disposable Contact Lenses.

Not Applicable
Completed
Conditions
Myopia
Interventions
Device: etafilcon A
Device: nelfilcon A
Registration Number
NCT00775021
Lead Sponsor
Johnson & Johnson Vision Care, Inc.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
123
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
etafilcon A/nelfilcon Aetafilcon Aetafilcon A contact lens worn first and nelfilcon A contact lens worn second
etafilcon A/nelfilcon Anelfilcon Aetafilcon A contact lens worn first and nelfilcon A contact lens worn second
nelfilcon A/etafilcon Anelfilcon Anelfilcon A contact lens worn first and etafilcon A contact lens second.
nelfilcon A/etafilcon Aetafilcon Anelfilcon A contact lens worn first and etafilcon A contact lens second.
Primary Outcome Measures
NameTimeMethod
Overall Comfort1 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 Outcome Measures
NameTimeMethod
Inferior Region Corneal Staining1 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)

End of the Day Comfort1 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.

Initial Comfort1 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.

Overall Lens Handling1 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.

Trial Locations

Locations (1)

Otometry Technology Group, Ltd.

🇬🇧

London, United Kingdom

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