Clinical trial NCT00813761: Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old.
* Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Require a visual correction in both eyes (monovision allowed but not monofit).
* Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
* Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
* Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Worn lenses on an extended wear basis in the last 3 months.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.

Primary outcomes:
measure: Average Daily Wear Time
timeFrame: 24 weeks
measure: Average Daily Comfortable Wear Time
timeFrame: 24 weeks
measure: Lens Comfort
timeFrame: 24 weeks
measure: Frequency of Eye Discomfort
timeFrame: 24 weeks
measure: Frequency of Daily Lens Dryness
timeFrame: 24 weeks
measure: Frequency of Eye Burning/Stinging
timeFrame: 24 weeks
measure: Frequency of Itching
timeFrame: 24 weeks
measure: Frequency of Tearing
timeFrame: 24 weeks
measure: Average Corneal Fluorescein Type Staining
timeFrame: 24 weeks
measure: Average Corneal Fluorescein Staining Area
timeFrame: 24 weeks
measure: Limbal Redness
timeFrame: 24 weeks
measure: Bulbar Redness
timeFrame: 24 weeks
measure: Lower Tarsal Redness
timeFrame: 24 weeks
measure: Upper Tarsal Redness
timeFrame: 24 weeks
measure: Tarsal Roughness
timeFrame: 24 weeks
Secondary outcomes:
measure: Intensity of Physiological Outcomes
timeFrame: 24 weeks
measure: Wearing Time and Comfortable Wearing Time
timeFrame: 24 weeks
measure: Physiological Responses
timeFrame: 24 weeks
Other outcomes:
Locations:
city: North Little Rock
country: United States
state: Arkansas
city: Campbell
country: United States
state: California
city: Cupertino
country: United States
state: California
city: Laguna Niguel
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: San Clemente
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Bloomington
country: United States
state: Illinois
city: Neodesha
country: United States
state: Kansas
city: Raytown
country: United States
state: Missouri
city: Warrensburg
country: United States
state: Missouri
city: Florence
country: United States
state: New Jersey
city: Chagrin Falls
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: Kittanning
country: United States
state: Pennsylvania
city: Moon
country: United States
state: Pennsylvania
city: Nanticoke
country: United States
state: Pennsylvania
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: Bartlett
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Midlothian
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Aston Triangle
country: United Kingdom
state: Birmingham
Study officials:
References: