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

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ClinicalTrials.gov Identifier: NCT01094743
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : January 25, 2012
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Device: galyfilcon A prototype lens Device: lotrafilcon B lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : February 1, 2010
Actual Primary Completion Date : March 1, 2010
Actual Study Completion Date : March 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
galyfilcon A prototype lens / lotrafilcon B lens
The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens
Silicone hydrogel contact lens

Device: lotrafilcon B lens
Silicon Hydrogel contact lens

lotrafilcon B lens / galyfilcon A prototype lens
The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens
Silicone hydrogel contact lens

Device: lotrafilcon B lens
Silicon Hydrogel contact lens




Primary Outcome Measures :
  1. Visual Acuity Monocular [ Time Frame: after 1 week of lens wear ]
    Snellen monocular visual acuity measurement

  2. Visual Acuity Binocular [ Time Frame: after 1 week of lens wear ]
    Snellen binocular visual acuity measurement

  3. Subjective Assessment of Lens Comfort [ Time Frame: after 1 week of lens wear ]
    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.

  4. Subjective Assessment of Quality of Vision [ Time Frame: after 1 week of lens wear ]
    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 :
  1. Limbal Redness [ Time Frame: after 1 week of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  2. Bulbar Redness [ Time Frame: after 1 week of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  3. Subjective Assessment of Lens Comfort [ Time Frame: 10 minutes after lens insertion at time of initial lens fitting ]
    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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must be at least 18 years of age and no more than 39 years of age.
  2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
  3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  4. Any cylinder power must be ≤ -0.75D.
  5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  6. The subject must read and sign the Statement of Informed Consent.
  7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
  2. Systemic disease or use of medication which might interfere with contact lens wear.
  3. 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.
  4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Pregnancy or lactation.
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094743


Locations
United States, Florida
Jacksonville, Florida, United States
United States, Virginia
Salem, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01094743     History of Changes
Other Study ID Numbers: CR-1636AZ
First Posted: March 29, 2010    Key Record Dates
Results First Posted: January 25, 2012
Last Update Posted: June 19, 2018
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes