Status:

COMPLETED

Daytime Corneal Swelling During Wear of Narafilcon B Lenses

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Myopia

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

Eligibility Criteria

Inclusion

  • Be of legal age (i.e. ≥ 18 years).
  • Be mentally competent, willing and able to sign a written informed consent form.
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
  • Have spectacle astigmatism \<1.25D in each eye.
  • Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion

  • Required concurrent ocular medication.
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight 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.

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT01444287

Start Date

January 1 2010

End Date

March 1 2010

Last Update

June 19 2018

Active Locations (1)

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Coles-Brennan Pty Ltd

Hawthorn, Victoria, Australia