Clinical trial NCT00975585: Clinical Performance Comparison of Two Contact Lenses
Official title: Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2009-09-11
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
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 two contact lenses.


Eligibility criteria: Inclusion Criteria:

* Existing daily soft lens wearer.
* Require a distance visual correction in both eyes.
* Have a contact lens spherical distance refraction between -1.00D and -6.00D.
* Have refractive astigmatism less than or equal to 1.00D in both eyes.
* Achieve 20/30 or better corrected distance acuity.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

* Requires presbyopic correction.
* Requires ocular medications.
* Grade 3 or 4 ocular abnormalities.
* Grade 3 corneal staining in more than one region.
* Has had refractive surgery.
* Any other injury or ocular surgery within 8 weeks prior to study enrollment.
* Has abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Has keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
* Wears habitual contact lenses that are toric, multifocal or worn extended wear.
* Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
* Diabetic.
* Infectious or immunosuppressive disease.
* History of chronic eye disease (e.g glaucoma or age related macular degeneration).
* Pregnancy, lactation or planning pregnancy at time of enrollment.
* Participation in any concurrent clinical trial or in another trial in the last 30 days.

Primary outcomes:
measure: Average Corneal Staining
timeFrame: 2 weeks
measure: Visual Acuity
timeFrame: 2 weeks
measure: Overall Comfort
timeFrame: 2 weeks
measure: Overall Comfort
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: Limbal Redness
timeFrame: 2 weeks
measure: Bulbar Redness
timeFrame: 2 weeks
measure: Symptoms of Dryness
timeFrame: 2 weeks
Other outcomes:
Locations:
city: North Little Rock
country: United States
state: Arkansas
city: Campbell
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Blue Springs
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Chagrin Falls
country: United States
state: Ohio
city: North Olmsted
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: State College
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Chamberlain
country: United States
state: South Dakota
city: Hot Springs
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: Burlington
country: United States
state: Vermont
city: West Allis
country: United States
state: Wisconsin
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Sheila, B Hickson-Curran, BSc, MCOptom
role: STUDY_DIRECTOR
References: