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Status:

COMPLETED

Comparison of Two Soft Bifocal Contact Lenses

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Presbyopia

Eligibility:

All Genders

35-70 years

Phase:

NA

Brief Summary

The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.

Eligibility Criteria

Inclusion

  • The subject must between 35 and 70 years of age.
  • The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
  • The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
  • Refractive cylinder must be -0.75 D in each eye.
  • The subject must have an ADD power of +0.75D to +2.50D in each eye.
  • The subject must have best corrected visual acuity of 20/20-3 or better in each eye
  • The subject's must have at least 20/30-distance vision OU with the study contact lenses.
  • The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear
  • Clinically significant (grade 3 or 4) tarsal abnormalities that 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
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of diabetes
  • History of binocular vision abnormality or strabismus

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

113 Patients enrolled

Trial Details

Trial ID

NCT00724945

Start Date

July 1 2008

End Date

August 1 2008

Last Update

May 21 2015

Active Locations (6)

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

Page 1 of 2 (6 locations)

1

Dr. James Weber & Associates

Jacksonville, Florida, United States, 32205

2

Ted Brink & Associates

Jacksonville, Florida, United States, 32256

3

Jacksonville, Florida, United States, 32256

4

Eye Associates of Winter Park

Winter Park, Florida, United States, 32792