Comparison of Three Soft Bifocal Contact Lenses

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24153

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity	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.	5 minutes after insertion
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity	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.	5 minutes after insertion
Type of Corneal Staining	Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).	after 1 week of lens wear, for each lens type
Overall Subjective Vision	Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	after 1 week of lens wear, for each lens type

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

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