Comparison of Three Soft Bifocal Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00808340
First received: December 12, 2008
Last updated: August 16, 2013
Last verified: August 2013
  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 production
Device: senofilcon A test

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 Bright Illumination Binocular Visual Performance Reported as Visual Acuity [ Time Frame: 5 minutes after insertion ] [ Designated as safety issue: No ]
    Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

  • Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity [ Time Frame: 5 minutes after insertion ] [ Designated as safety issue: No ]
    Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

  • Type of Corneal Staining [ Time Frame: after 1 week of lens wear, for each lens type ] [ Designated as safety issue: No ]
    Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).

  • Overall Subjective Vision [ Time Frame: after 1 week of lens wear, for each lens type ] [ Designated as safety issue: No ]
    Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.


Enrollment: 37
Study Start Date: November 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: senofilA test/senofilA prod/balafilconA
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
multifocal contact lens
Active Comparator: senofilcon A test/balafilcon A/senofilcon A prod
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
multifocal contact lens
Active Comparator: senofilcon A prod/senofilcon A test/balafilcon A
Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
multifocal contact lens
Active Comparator: senofilcon A prod/ balifilcon A/ senofilcon A test
Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
multifocal contact lens
Active Comparator: balafilcon A/senofilcon A test/senofilcon A prod
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
multifocal contact lens
Active Comparator: balafilcon A/senofilcon A prod/senofilcon A test
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.
Device: balafilcon A
multifocal contact lens
Device: senofilcon A production
multifocal contact lens
Device: senofilcon A test
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 respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" 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 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 a contagious 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: NCT00808340

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

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00808340     History of Changes
Other Study ID Numbers: CR-1485FA
Study First Received: December 12, 2008
Results First Received: July 30, 2010
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 20, 2014