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Clinical Trials/NCT00727558
NCT00727558
Completed
Not Applicable

A Comparison of Daily Disposable Contact Lenses.

Johnson & Johnson Vision Care, Inc.19 sites in 1 country248 target enrollmentJuly 2008
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Johnson & Johnson Vision Care, Inc.
Enrollment
248
Locations
19
Primary Endpoint
Overall Comfort
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
October 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  • They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  • They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  • They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  • They have diabetes.

Outcomes

Primary Outcomes

Overall Comfort

Time Frame: at 1 week of wear.

Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

Measured Limbal Hyperemia

Time Frame: at 1 week of wear.

Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Secondary Outcomes

  • Overall Handling(at 1 week of wear)
  • How Comfortable Eyes Feel at the End of the Day(at 1 week wear)
  • End of Day Comfort(at 1 week of wear)
  • Initial Comfort(at 1 week)
  • Inferior Region Corneal Staining(at 1 week of wear)

Study Sites (19)

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