Status:

COMPLETED

Clinical Performance Comparison of Two Contact Lenses

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Collaborating Sponsors:

Visioncare Research Ltd.

Conditions:

Myopia

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief Summary

The purpose of this study is to compare the clinical performance of two contact lenses.

Eligibility Criteria

Inclusion

  • Existing daily soft lens wearer.
  • Require a distance visual correction in both eyes.
  • Have a contact lens spherical distance refraction between -1.00D and -6.00D.
  • Have refractive astigmatism less than or equal to 1.00D in both eyes.
  • Achieve 20/30 or better corrected distance acuity.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion

  • Requires presbyopic correction.
  • Requires ocular medications.
  • Grade 3 or 4 ocular abnormalities.
  • Grade 3 corneal staining in more than one region.
  • Has had refractive surgery.
  • Any other injury or ocular surgery within 8 weeks prior to study enrollment.
  • Has abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Has keratoconus or other corneal irregularity.
  • Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
  • Wears habitual contact lenses that are toric, multifocal or worn extended wear.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
  • Diabetic.
  • Infectious or immunosuppressive disease.
  • History of chronic eye disease (e.g glaucoma or age related macular degeneration).
  • Pregnancy, lactation or planning pregnancy at time of enrollment.
  • Participation in any concurrent clinical trial or in another trial in the last 30 days.

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

379 Patients enrolled

Trial Details

Trial ID

NCT00975585

Start Date

August 1 2009

End Date

October 1 2009

Last Update

June 19 2018

Active Locations (25)

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Page 1 of 7 (25 locations)

1

North Little Rock, Arkansas, United States, 72116

2

Campbell, California, United States, 95008

3

Colorado Springs, Colorado, United States, 80909

4

Jacksonville, Florida, United States, 32205