Comparison of Two Soft Bifocal Contact Lenses

Presbyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724945
• Other study ID #: CR-1485CK
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: May 5, 2015
• Start date: July 2008
• Est. completion date: August 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• balafilcon A
multifocal contact lens
• senofilcon A
multifocal contact lens

Locations

Country	Name	City	State
United States	Lee Rigel	East Lansing	Michigan
United States	Dr. James Weber & Associates	Jacksonville	Florida
United States	Ted Brink & Associates	Jacksonville	Florida
United States	Timothy R. Poling, OD	Roanoke	Virginia
United States	Eye Associates of Winter Park	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No