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

Refractive Ametropia Clinical Trial

Official title:

Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484028
• Other study ID #: CR-005094
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

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.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• etafilcon A control lens (1DM)
A marketed daily disposable contact lens
• etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
• etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens

Locations

Country	Name	City	State
United States	Eye Care Associates	Bloomington	Illinois
United States	Vision Care	East Lansing	Michigan
United States	The Eye Care Group	Grants Pass	Oregon
United States	Spectrum Eye Care	Jamestown	New York
United States	Wishnow Sugar Group	Katy	Texas
United States	Snowy Range Cision Center	Laramie	Wyoming
United States	Isthmus Eye Care	Middleton	Wisconsin
United States	Advanced Optometry	Mission Viejo	California
United States	James R Dugue, Optometrist	Mission Viejo	California
United States	Advance Eye Care	Pismo Beach	California
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Golden Vision	Sarasota	Florida
United States	Sacco Eye Group	Vestal	New York
United States	Dr. David W Ferris and Associates	Warwick	Rhode Island
United States	Eye Associates of Winter Park	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Visual Acuity	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.	Dispensing
Primary	Lens Fit Acceptance	The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).	Dispensing
Primary	Corneal Staining of Grade 3 or 4	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.	After 7-9 days of lens wear