Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
- Conditions
- Refractive Ametropia
- Interventions
- Device: etafilcon A control lens (1DM)Device: etafilcon A with print and PVP for light eyes (EALE)Device: etafilcon A with print and PVP for dark eyes (EADE)
- Registration Number
- NCT01484028
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 275
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1DM/EADE etafilcon A control lens (1DM) etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. EALE/1DM etafilcon A control lens (1DM) etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. EADE/1DM etafilcon A control lens (1DM) etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. EALE/1DM etafilcon A with print and PVP for light eyes (EALE) etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. EADE/1DM etafilcon A with print and PVP for dark eyes (EADE) etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. 1DM/EADE etafilcon A with print and PVP for dark eyes (EADE) etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. 1DM/EALE etafilcon A control lens (1DM) etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. 1DM/EALE etafilcon A with print and PVP for light eyes (EALE) etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
- 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
Trial Locations
- Locations (15)
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Snowy Range Cision Center
🇺🇸Laramie, Wyoming, United States
Isthmus Eye Care
🇺🇸Middleton, Wisconsin, United States
The Eye Care Group
🇺🇸Grants Pass, Oregon, United States
Eye Associates of Winter Park
🇺🇸Winter Park, Florida, United States
Advance Eye Care
🇺🇸Pismo Beach, California, United States
James R Dugue, Optometrist
🇺🇸Mission Viejo, California, United States
Advanced Optometry
🇺🇸Mission Viejo, California, United States
Golden Vision
🇺🇸Sarasota, Florida, United States
Eye Care Associates
🇺🇸Bloomington, Illinois, United States
Sacco Eye Group
🇺🇸Vestal, New York, United States
Spectrum Eye Care
🇺🇸Jamestown, New York, United States
Dr. David W Ferris and Associates
🇺🇸Warwick, Rhode Island, United States
Wishnow Sugar Group
🇺🇸Katy, Texas, United States
Vision Care
🇺🇸East Lansing, Michigan, United States