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Status:

TERMINATED

Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Collaborating Sponsors:

Johnson & Johnson

Conditions:

Refractive Error

Myopia

Eligibility:

All Genders

18-39 years

Phase:

NA

Brief Summary

This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patien...

Eligibility Criteria

Inclusion

  • The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
  • The subject has signed an informed consent with his/her own judgement for participation in the study.
  • The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.

Exclusion

  • The subject has any ocular or systemic allergies that interfere with contact lens wear.
  • The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
  • The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
  • The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
  • The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
  • The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
  • The subject has ocular infection.
  • The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
  • The subject has corneal distortion resulting from previous experience of hard contact lens wear.
  • The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
  • The subject has diabetes, as far as known to the subject.
  • The subject is pregnant or in the lactation period, as far as known to the subject.
  • The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
  • The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
  • The subject is a wearer of hard contact lenses (including rigid gas permeable).
  • The subject is exposed to a dry environment on a constant basis.
  • The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
  • The subject is unable to follow the principal investigator's instructions.
  • The subject is unable to follow lens hygiene procedures necessary for contact lens wear.

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT00639353

Start Date

February 1 2008

Last Update

October 29 2014

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Shioya eye clinic

Fukushima, Fukushima, Japan

2

Takahashi eye clinic

Odawarashi, Kanagawa, Japan

3

Kodama eye clinic

Jyoyoshi, Kyoto, Japan

4

Inaba eye clinic

Osakashi, Osaka, Japan