Clinical trial NCT00808340: Comparison of Three 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: 2008-12-15
Enrollment: 37
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
timeFrame: 5 minutes after insertion
measure: Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
timeFrame: 5 minutes after insertion
measure: Type of Corneal Staining
timeFrame: after 1 week of lens wear, for each lens type
measure: Overall Subjective Vision
timeFrame: after 1 week of lens wear, for each lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
state: Virginia
Study officials:
References: