Clinical trial NCT00724945: Comparison of Two Soft Bifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 113
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: after 1 week of wear
measure: Near Visual Acuity
timeFrame: after 1 week wear
measure: Subject Vision
timeFrame: after 1 week wear
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates
state: Florida
city: Jacksonville
country: United States
facility: Ted Brink & Associates
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: East Lansing
country: United States
facility: Lee Rigel
state: Michigan
city: Roanoke
country: United States
facility: Timothy R. Poling, OD
state: Virginia
Study officials:
References: