Comparison of Two Soft Bifocal Contact Lenses

NCT00724945 | Completed Results

• 1 other identifier: CR-1485CK
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

senofilcon A / balafilcon A

ACTIVE COMPARATOR

senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second

Device: balafilcon A; Device: senofilcon A

balafilcon A/senofilcon A

ACTIVE COMPARATOR

balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second

Device: balafilcon A; Device: senofilcon A

Interventions

balafilcon A DEVICE

multifocal contact lens

balafilcon A/senofilcon A; senofilcon A / balafilcon A

senofilcon A DEVICE

multifocal contact lens

balafilcon A/senofilcon A; senofilcon A / balafilcon A

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (6)

Dr. James Weber & Associates

Jacksonville, Florida, 32205, United States

Location

Ted Brink & Associates

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Eye Associates of Winter Park

Winter Park, Florida, 32792, United States

Location

Lee Rigel

East Lansing, Michigan, 48823, United States

Location

Timothy R. Poling, OD

Roanoke, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Thomas Karkkainen OD
• Organization: Vistakon

tkarkkai@its.jnj.com

904-443-3402

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: January 27, 2010

Record last verified: 2015-05

Locations

US (6)