Comparison of Three Soft Bifocal Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test

• Registration Number: NCT00808340
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-01
• Primary Completion: 2008-12-01
• Study Completion: 2008-12-01
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Results First Submitted: 2010-07-30
• Results First Submitted QC: 2010-07-30
• Results First Posted: 2010-08-26
• Status Verified: 2017-08
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
senofilA test/senofilA prod/balafilconA	senofilcon A production	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
senofilcon A test/balafilcon A/senofilcon A prod	senofilcon A production	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
senofilcon A prod/senofilcon A test/balafilcon A	senofilcon A test	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
senofilA test/senofilA prod/balafilconA	balafilcon A	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
senofilcon A test/balafilcon A/senofilcon A prod	senofilcon A test	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
senofilcon A prod/ balifilcon A/ senofilcon A test	senofilcon A test	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
balafilcon A/senofilcon A test/senofilcon A prod	balafilcon A	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
balafilcon A/senofilcon A prod/senofilcon A test	balafilcon A	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.
senofilA test/senofilA prod/balafilconA	senofilcon A test	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
senofilcon A prod/senofilcon A test/balafilcon A	balafilcon A	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
senofilcon A prod/senofilcon A test/balafilcon A	senofilcon A production	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
senofilcon A prod/ balifilcon A/ senofilcon A test	balafilcon A	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
senofilcon A prod/ balifilcon A/ senofilcon A test	senofilcon A production	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
senofilcon A test/balafilcon A/senofilcon A prod	balafilcon A	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
balafilcon A/senofilcon A test/senofilcon A prod	senofilcon A production	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
balafilcon A/senofilcon A test/senofilcon A prod	senofilcon A test	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
balafilcon A/senofilcon A prod/senofilcon A test	senofilcon A production	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.
balafilcon A/senofilcon A prod/senofilcon A test	senofilcon A test	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.

Primary Outcome Measures

Name	Time	Method
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity	5 minutes after insertion	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.
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity	5 minutes after insertion	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.
Type of Corneal Staining	after 1 week of lens wear, for each lens type	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	after 1 week of lens wear, for each lens type	Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.