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

NCT01484028 | Completed Results

• 1 other identifier: CR-005094
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Refractive Ametropia

Outcome Measures

Primary Outcomes (3)

• 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

• Lens Fit Acceptance

  The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).

  Dispensing

• 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

Study Arms (4)

EALE/1DM

OTHER

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.

Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for light eyes (EALE)

1DM/EALE

OTHER

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.

Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for light eyes (EALE)

EADE/1DM

OTHER

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.

Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for dark eyes (EADE)

1DM/EADE

OTHER

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.

Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for dark eyes (EADE)

Interventions

etafilcon A control lens (1DM) DEVICE

A marketed daily disposable contact lens

Also known as: 1-DAY ACUVUE MOIST Brand Contact Lenses

1DM/EADE; 1DM/EALE; EADE/1DM; EALE/1DM

etafilcon A with print and PVP for light eyes (EALE) DEVICE

A daily disposable contact lens

1DM/EALE; EALE/1DM

etafilcon A with print and PVP for dark eyes (EADE) DEVICE

A daily disposable contact lens

1DM/EADE; EADE/1DM

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (15)

Advanced Optometry

Mission Viejo, California, 92691, United States

Location

James R Dugue, Optometrist

Mission Viejo, California, 92691, United States

Location

Advance Eye Care

Pismo Beach, California, 93448, United States

Location

Golden Vision

Sarasota, Florida, 34242, United States

Location

Eye Associates of Winter Park

Winter Park, Florida, 32789, United States

Location

Eye Care Associates

Bloomington, Illinois, 61701, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Vision Care

East Lansing, Michigan, 48826, United States

Location

Spectrum Eye Care

Jamestown, New York, 14702, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

The Eye Care Group

Grants Pass, Oregon, 97526, United States

Location

Dr. David W Ferris and Associates

Warwick, Rhode Island, 02887, United States

Location

Wishnow Sugar Group

Katy, Texas, 77450, United States

Location

Isthmus Eye Care

Middleton, Wisconsin, 53562, United States

Location

Snowy Range Cision Center

Laramie, Wyoming, 82070, United States

Location

Results Point of Contact

• Title: Dr. Michael Mayers, O.D., FAAO, Senior Research Optometrist
• Organization: Vistakon, Johnson and Johnson Vision Care

mmayers@its.jnj.com

1 904 443 3252

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 19, 2018
• Results First Posted: November 15, 2013

Record last verified: 2015-05

Locations

US (15)