Comparison of Two Soft Bifocal Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: balafilcon A; Device: senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity	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	after 1 week of wear
Near Visual Acuity	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.	after 1 week wear
Subject Vision	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.	after 1 week wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CR-1485CK