Comparison of Two Soft Bifocal Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00724945
First received: July 25, 2008
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Presbyopia
Device: balafilcon A
Device: senofilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Distance Visual Acuity [ Time Frame: after 1 week of wear ] [ Designated as safety issue: No ]
    This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal

  • Near Visual Acuity [ Time Frame: after 1 week wear ] [ Designated as safety issue: No ]
    This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.

  • Subject Vision [ Time Frame: after 1 week wear ] [ Designated as safety issue: No ]
    Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.


Enrollment: 113
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: senofilcon A / balafilcon A
senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second
Device: balafilcon A
multifocal contact lens
Device: senofilcon A
multifocal contact lens
Active Comparator: balafilcon A/senofilcon A
balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second
Device: balafilcon A
multifocal contact lens
Device: senofilcon A
multifocal contact lens

  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 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 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724945

Locations
United States, Florida
Jacksonville, Florida, United States, 32256
Dr. James Weber & Associates
Jacksonville, Florida, United States, 32205
Ted Brink & Associates
Jacksonville, Florida, United States, 32256
Eye Associates of Winter Park
Winter Park, Florida, United States, 32792
United States, Michigan
Lee Rigel
East Lansing, Michigan, United States, 48823
United States, Virginia
Timothy R. Poling, OD
Roanoke, Virginia, United States, 24153
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00724945     History of Changes
Other Study ID Numbers: CR-1485CK
Study First Received: July 25, 2008
Results First Received: September 25, 2009
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 23, 2014