Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01180985
First received: August 11, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.


Condition Intervention
Myopia
Device: galyfilcon A prototype lens
Device: comfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Visual Acuity Monocular [ Time Frame: after 7 +/- 1 days of lens wear ] [ Designated as safety issue: No ]
    Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

  • Visual Acuity Binocular [ Time Frame: after 7 +/- 1 days of lens wear ] [ Designated as safety issue: No ]
    Snellen binocular visual acuity measurement

  • Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. [ Time Frame: after 7 +/-1 days of lens wear ] [ Designated as safety issue: No ]
    The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.

  • Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. [ Time Frame: after 7 +/- 1 days of lens wear ] [ Designated as safety issue: No ]
    Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.


Secondary Outcome Measures:
  • Limbal Redness [ Time Frame: after 7 days of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  • Bulbar Redness [ Time Frame: after 7 days of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  • Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. [ Time Frame: 10 minutes after lens insertion at time of initial lens fitting ] [ Designated as safety issue: No ]
    Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.


Enrollment: 53
Study Start Date: June 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
galyfilcon A prototype/comfilcon A
The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens
silicone hydrogel contact lens
Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens
comfilcon A/galyfilcon A prototype
The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens
silicone hydrogel contact lens
Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • 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 the clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, 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.
  • 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.
  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: NCT01180985

Locations
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Virginia
Fincastle, Virginia, United States
Salem, Virginia, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01180985     History of Changes
Other Study ID Numbers: CR-1636BD
Study First Received: August 11, 2010
Results First Received: November 7, 2011
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014