Clinical trial NCT01244516: Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.


Eligibility criteria: Inclusion Criteria:

* Be no less than 18 and no more than 39 years of age.
* Sign Written Informed Consent and investigator to record this on Case Report Form.
* Be willing and able to adhere to the instructions set out in the protocol.
* Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
* No extended wear in the last 3 months.
* Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
* Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
* Achieve visual acuity of 6/9 (20/30) or better in each eye.
* Require a visual correction in both eyes (no monovision allowed).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Clinically significant corneal staining
* Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
* Has had refractive surgery.
* Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\].
* History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 30 days

Primary outcomes:
measure: Overall Subjective Comfort
timeFrame: after 2 weeks of contact lens wear
measure: Corneal Staining
timeFrame: after 2 weeks of contact lens wear
Secondary outcomes:
measure: Overall Subjective Lens Handling
timeFrame: after 2 weeks of contact lens wear
Other outcomes:
Locations:
city: Brea
country: United States
state: California
city: Campbell
country: United States
state: California
city: Cupertino
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Jacksonville
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: Bloomington
country: United States
state: Illinois
city: Mishawaka
country: United States
state: Indiana
city: Pittsburg
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Independence
country: United States
state: Missouri
city: Raytown
country: United States
state: Missouri
city: Closter
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: North Olmsted
country: United States
state: Ohio
city: Powell
country: United States
state: Ohio
city: Kittanning
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Chamberlain
country: United States
state: South Dakota
city: Bartlett
country: United States
state: Tennessee
city: Brentwood
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Tyler
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Salem
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
Study officials:
References: