Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Not Applicable

Completed

Brief Summary: This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Recruitment & Eligibility

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 Outcome Measures

Name	Time	Method
Lens Fit Acceptance	Dispensing	The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Monocular Visual Acuity	Dispensing	Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Corneal Staining of Grade 3 or 4	After 7-9 days of lens wear	Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade \>= 3 were reported.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Advanced Optometry
🇺🇸
Mission Viejo, California, United States
James R Dugue, Optometrist
🇺🇸
Mission Viejo, California, United States
Advance Eye Care
🇺🇸
Pismo Beach, California, United States
Golden Vision
🇺🇸
Sarasota, Florida, United States
Eye Associates of Winter Park
🇺🇸
Winter Park, Florida, United States
Eye Care Associates
🇺🇸
Bloomington, Illinois, United States
Kannarr Eye Care
🇺🇸
Pittsburg, Kansas, United States
Vision Care
🇺🇸
East Lansing, Michigan, United States
Spectrum Eye Care
🇺🇸
Jamestown, New York, United States
Sacco Eye Group
🇺🇸
Vestal, New York, United States
Scroll for more (5 remaining)
Advanced Optometry
🇺🇸Mission Viejo, California, United States