Status:

COMPLETED

Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Myopia

Eligibility:

All Genders

18-39 years

Phase:

NA

Brief Summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Eligibility Criteria

Inclusion

  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2010

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT01180985

Start Date

June 1 2010

End Date

July 1 2010

Last Update

June 19 2018

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Jacksonville, Florida, United States

2

Orlando, Florida, United States

3

Fincastle, Virginia, United States

4

Salem, Virginia, United States