Clinical trial NCT01484054: Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens
Official title: Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the performance of a new contact lens to a marketed contact lens.


Eligibility criteria: Inclusion Criteria:

* The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
* The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
* The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
* The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
* The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
* The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
* Any cylinder power must be:\<=0.75D.
* The subject must have visual acuity best correctable to 20/25 or better for each eye.
* The subject must have normal eyes (no ocular medications or ocular infection of any type).
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Any color deficiencies (color blindness) - to the best of the subject's knowledge.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
* Subject presents with one dark iris color and one light iris color
* Subject has heterochromia iridis (a difference in color between parts of one iris)
* The subject is an employee or family member of the clinical study site.

Primary outcomes:
measure: Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
timeFrame: After 7 to 9 days of lens wear
measure: Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
timeFrame: After 7 to 9 days of lens wear
measure: Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
timeFrame: After 7 to 9 days of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield
country: United States
state: Connecticut
city: Tallahassee
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: Jamestown
country: United States
state: New York
city: Kingston
country: United States
state: Pennsylvania
city: Moon
country: United States
state: Pennsylvania
Study officials:
References: