Clinical trial NCT01484028: Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
Official title: Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light 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: 275
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: This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.


Eligibility criteria: Inclusion Criteria:

* Healthy, female adult, at least 18 years of age, and no more than 34 years of age
* The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
* Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
* Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
* Any cylinder power must be: \<=0.75D
* Visual acuity must be best correctable to 20/25 or better for each eye
* Must have normal eyes (no ocular medications or ocular infection of any type)
* Must read and sign the Statement of Informed Consent
* 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 (colorblindness) - 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 must not be an employee or family member of the clinical study site.

Primary outcomes:
measure: Monocular Visual Acuity
timeFrame: Dispensing
measure: Lens Fit Acceptance
timeFrame: Dispensing
measure: Corneal Staining of Grade 3 or 4
timeFrame: After 7-9 days of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Advanced Optometry
state: California
city: Mission Viejo
country: United States
facility: James R Dugue, Optometrist
state: California
city: Pismo Beach
country: United States
facility: Advance Eye Care
state: California
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: Bloomington
country: United States
facility: Eye Care Associates
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: East Lansing
country: United States
facility: Vision Care
state: Michigan
city: Jamestown
country: United States
facility: Spectrum Eye Care
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Grants Pass
country: United States
facility: The Eye Care Group
state: Oregon
city: Warwick
country: United States
facility: Dr. David W Ferris and Associates
state: Rhode Island
city: Katy
country: United States
facility: Wishnow Sugar Group
state: Texas
city: Middleton
country: United States
facility: Isthmus Eye Care
state: Wisconsin
city: Laramie
country: United States
facility: Snowy Range Cision Center
state: Wyoming
Study officials:
References: