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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01484028
First received: November 30, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Refractive Ametropia
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Monocular Visual Acuity [ Time Frame: Dispensing ] [ Designated as safety issue: No ]
    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.

  • Lens Fit Acceptance [ Time Frame: Dispensing ] [ Designated as safety issue: No ]
    The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).

  • Corneal Staining of Grade 3 or 4 [ Time Frame: After 7-9 days of lens wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 275
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
EALE/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.
Device: etafilcon A control lens (1DM)
A marketed daily disposable contact lens
Other Name: 1-DAY ACUVUE MOIST Brand Contact Lenses
Device: etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
1DM/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.
Device: etafilcon A control lens (1DM)
A marketed daily disposable contact lens
Other Name: 1-DAY ACUVUE MOIST Brand Contact Lenses
Device: etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
EADE/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.
Device: etafilcon A control lens (1DM)
A marketed daily disposable contact lens
Other Name: 1-DAY ACUVUE MOIST Brand Contact Lenses
Device: etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens
1DM/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.
Device: etafilcon A control lens (1DM)
A marketed daily disposable contact lens
Other Name: 1-DAY ACUVUE MOIST Brand Contact Lenses
Device: etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484028

Locations
United States, California
Advanced Optometry
Mission Viejo, California, United States, 92691
James R Dugue, Optometrist
Mission Viejo, California, United States, 92691
Advance Eye Care
Pismo Beach, California, United States, 93448
United States, Florida
Golden Vision
Sarasota, Florida, United States, 34242
Eye Associates of Winter Park
Winter Park, Florida, United States, 32789
United States, Illinois
Eye Care Associates
Bloomington, Illinois, United States, 61701
United States, Kansas
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
United States, Michigan
Vision Care
East Lansing, Michigan, United States, 48826
United States, New York
Spectrum Eye Care
Jamestown, New York, United States, 14702
Sacco Eye Group
Vestal, New York, United States, 13850
United States, Oregon
The Eye Care Group
Grants Pass, Oregon, United States, 97526
United States, Rhode Island
Dr. David W Ferris and Associates
Warwick, Rhode Island, United States, 02887
United States, Texas
Wishnow Sugar Group
Katy, Texas, United States, 77450
United States, Wisconsin
Isthmus Eye Care
Middleton, Wisconsin, United States, 53562
United States, Wyoming
Snowy Range Cision Center
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01484028     History of Changes
Other Study ID Numbers: CR-005094
Study First Received: November 30, 2011
Results First Received: August 30, 2013
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014