MedPath

Clinical Evaluation of Two Daily Disposable Contact Lenses

Not Applicable
Completed
Conditions
Refractive Error
Registration Number
NCT01163760
Lead Sponsor
Johnson & Johnson Vision Care, Inc.
Brief Summary

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Be between 21 and 39 years of age.

  • Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.

  • Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).

  • Require a visual correction in both eyes (monovision allowed but no monofit).

  • Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.

  • Astigmatism of 1.00D or less in both eyes.

  • Be able to wear the lens powers available for this study.

  • Be correctable to a visual acuity of 20/30 or better in each eye.

  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No amblyopia.
    • No evidence of lid abnormality or infection.
    • No conjunctival abnormality or infection.
    • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
    • No other active ocular disease.
Exclusion Criteria
  • Requires concurrent ocular medication.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Diabetic.
  • Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Extended lens wear in last 3 months.
  • PMMA or RGP lens wear in the previous 8 weeks.
  • Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial or in last 60 days."

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Lens Comfort1-week follow-up

Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Secondary Outcome Measures
NameTimeMethod
Comfort Throughout the Whole Day1-week follow-up

Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.