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Status:

COMPLETED

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Refractive Ametropia

Eligibility:

FEMALE

18-34 years

Phase:

NA

Brief Summary

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Eligibility Criteria

Inclusion

  • The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
  • The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
  • The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
  • The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  • The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  • The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
  • Any cylinder power must be:\<=0.75D.
  • The subject must have visual acuity best correctable to 20/25 or better for each eye.
  • The subject must have normal eyes (no ocular medications or ocular infection of any type).
  • 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 this clinical protocol.

Exclusion

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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.
  • Any color deficiencies (color blindness) - to the best of the subject's knowledge.
  • 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.
  • Subject presents with one dark iris color and one light iris color
  • Subject has heterochromia iridis (a difference in color between parts of one iris)
  • The subject is an employee or family member of the clinical study site.

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2012

Estimated Enrollment :

103 Patients enrolled

Trial Details

Trial ID

NCT01484054

Start Date

November 1 2011

End Date

February 1 2012

Last Update

June 19 2018

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Bloomfield, Connecticut, United States, 06002

2

Tallahassee, Florida, United States, 32308

3

Overland Park, Kansas, United States, 66207

4

Jamestown, New York, United States, 14750