Clinical trial NCT02223754: Evaluation of an Investigational Multifocal Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 371
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 purpose of this study is to test the performance of an investigational multifocal test soft contact lens.


Eligibility criteria: Inclusion Criteria:

1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 40 and 70 years of age.
4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
5. 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 of more duration)
6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"\*
7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
8. Refractive cylinder ≤ -0.75 D in each eye.
9. ADD power in the range +0.75 D to +2.50 D in each eye.
10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
4. Any ocular abnormality that may have interfered with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. History of herpetic keratitis.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
12. 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.
13. Any ocular infection or inflammation.
14. Any corneal distortion or irregular cornea.

Primary outcomes:
measure: Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
timeFrame: 8 -12 days post wear
measure: Distance Binocular Visual Acuity (LogMAR)
timeFrame: 8- 12 Days post wear
measure: Intermediate Binocular Visual Acuity (LogMAR)
timeFrame: 8-12 days post wear
measure: Near Binocular Visual Acuity (LogMAR)
timeFrame: 8-12 days post wear
measure: Corneal Staining
timeFrame: 8 - 12 Days post wear
measure: Bulbar Conjunctival Injection
timeFrame: 8- 12 Days post wear
measure: Limbal Conjunctival Injection
timeFrame: 8- 12 Days post wear
measure: Contact Lens Fitting
timeFrame: 8- 12 Days post wear
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Mission Viejo
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Saint Augustine
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Pittsburg
country: United States
state: Kansas
city: East Lansing
country: United States
state: Michigan
city: Vestal
country: United States
state: New York
city: Denver
country: United States
state: North Carolina
city: Powell
country: United States
state: Ohio
city: Springfield
country: United States
state: Ohio
city: Warwick
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Tyler
country: United States
state: Texas
city: Salem
country: United States
state: Virginia
Study officials:
References: