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Comparison of Three Soft Bifocal Contact Lenses
This study has been completed.
First Received: December 12, 2008   Last Updated: January 30, 2009   History of Changes
Sponsored by: Vistakon
Information provided by: Vistakon
ClinicalTrials.gov Identifier: NCT00808340
  Purpose

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.


Condition Intervention
Presbyopia
Device: balafilcon A
Device: senofilcon A

MedlinePlus related topics: Eye Wear
Drug Information available for: Balafilcon A Senofilcon A
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Crossover Assignment

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • logMar visual acuity [ Time Frame: all follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective vision [ Time Frame: all follow-up visits ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: November 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
balafilcon A multifocal
Device: balafilcon A
multifocal contact lens
2: Active Comparator
senofilcon A multifocal
Device: senofilcon A
multifocal contact lens
3: Experimental
senofilcon A test design
Device: senofilcon A
test design

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject must between 35 and 70 years of age.
  • The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (see Appendix A) or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
  • The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
  • Refractive cylinder must be less than or equal to -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 Criteria:

  • 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 (see Appendix B).
  • 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 a contagious immunosuppressive disease (e.g., HIV).
  • History of diabetes10. History of binocular vision abnormality or strabismus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808340

Locations
United States, Virginia
Roanoke, Virginia, United States, 24153
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon ( Tom Karkkainen, OD, Principal Research Optometrist )
Study ID Numbers: CR-1485FA
Study First Received: December 12, 2008
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00808340     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Eye Diseases
Presbyopia
Refractive Errors

Additional relevant MeSH terms:
Eye Diseases
Presbyopia
Refractive Errors

ClinicalTrials.gov processed this record on May 07, 2009