Clinical trial NCT01763047: Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 298
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the performance of a novel multifocal lens system.


Eligibility criteria: Inclusion Criteria:

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. Subjects must be between 40 and 70 years of age.
4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
8. Subjects' should own a wearable pair of spectacles.
9. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
5. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
6. Any ocular infection.
7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Primary outcomes:
measure: Binocular Distance Visual Acuity (LogMAR)
timeFrame: 8-12 days post wear
measure: Binocular Near Visual Acuity (logMAR)
timeFrame: 8-12 days post wear
measure: Percentage of Eyes With Corneal Staining Grade 3 or Higher
timeFrame: 8-12 days post wear
measure: Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
timeFrame: 8-12 days post wear
measure: Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
timeFrame: 8-12 days post wear
measure: CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire
timeFrame: 8-12 days post wear
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
state: California
city: Jacksonville
country: United States
facility: RPS
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Saint Augustine
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Lutherville
country: United States
state: Maryland
city: Closter
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Denver
country: United States
state: North Carolina
city: Athens
country: United States
state: Ohio
city: Kingston
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salem
country: United States
state: Virginia
Study officials:
References: