Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01484054
First received: November 30, 2011
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

To evaluate and compare the performance of a new contact lens to a marketed contact lens.


Condition Intervention
Refractive Ametropia
Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)
Device: etafilcon A control lens (EADE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ] [ Designated as safety issue: No ]
    The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.

  • Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ] [ Designated as safety issue: No ]
    The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  • Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ] [ Designated as safety issue: No ]
    The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.


Enrollment: 103
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
EAPVPDE/EADE
etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)
A daily disposable contact lens
Device: etafilcon A control lens (EADE)
A marketed daily disposable contact lens
EADE/EAPVPDE
etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)
A daily disposable contact lens
Device: etafilcon A control lens (EADE)
A marketed 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:

  • The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
  • The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
  • The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
  • The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  • The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  • The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
  • Any cylinder power must be:<=0.75D.
  • The subject must have visual acuity best correctable to 20/25 or better for each eye.
  • The subject must have normal eyes (no ocular medications or ocular infection of any type).
  • The subject must read and sign the Statement of Informed Consent.
  • The subject 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 (color blindness) - 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 is 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: NCT01484054

Locations
United States, Connecticut
Bloomfield, Connecticut, United States, 06002
United States, Florida
Tallahassee, Florida, United States, 32308
United States, Kansas
Overland Park, Kansas, United States, 66207
United States, New York
Jamestown, New York, United States, 14750
United States, Pennsylvania
Kingston, Pennsylvania, United States, 18704
Moon Township, Pennsylvania, United States, 15108
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01484054     History of Changes
Other Study ID Numbers: CR-005128
Study First Received: November 30, 2011
Results First Received: August 30, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014