Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01482819
First received: November 16, 2011
Last updated: April 1, 2013
Last verified: April 2013

November 16, 2011
April 1, 2013
October 2011
December 2011   (final data collection date for primary outcome measure)
  • Corneal Swelling [ Time Frame: after 8 hours of lens wear ] [ Designated as safety issue: Yes ]
    measured in microns with pachymetry equipment, reported as percentage of swelling from approximately -10% to +10%
  • Limbal Redness [ Time Frame: after 8 hours of lens wear ] [ Designated as safety issue: No ]
    grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
  • Endothelia Blebs [ Time Frame: after 20 minutes of lens wear ] [ Designated as safety issue: No ]
    0 to 100% of area; measured as a percentage of corneal area with blebs.
Same as current
Complete list of historical versions of study NCT01482819 on ClinicalTrials.gov Archive Site
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Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
Not Provided

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • Device: galyfilcon A
    contact lenses worn bilaterally for 8-12 hours
  • Device: galyfilcon A plus
    contact lenses worn bilaterally for 8-12 hours
  • Device: lotrafilcon A
    contact lenses worn bilaterally for 8-12 hours
  • Device: polymacon
    contact lenses worn bilaterally for 8-12 hours
  • Other: spectacles
    habitual spectacles owned by subject, non-specific manufacturer
  • Sequence 1

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Lotrafilcon A
    2. Spectacles
    3. Galyfilcon A Plus
    4. Polymacon
    5. Galyfilcon A
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 2

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Galyfilcon A Plus
    2. Galyfilcon A
    3. Lotrafilcon A
    4. Polymacon
    5. Spectacles
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 3

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Galyfilcon A
    2. Polymacon
    3. Galyfilcon A Plus
    4. Spectacles
    5. Lotrafilcon A
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 4

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Spectacles
    2. Lotrafilcon A
    3. Polymacon
    4. Galyfilcon A Plus
    5. Galyfilcon A
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 5

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Polymacon
    2. Galyfilcon A
    3. Spectacles
    4. Galyfilcon A Plus
    5. Lotrafilcon A
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 6

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Galyfilcon A
    2. Galyfilcon A Plus
    3. Polymacon
    4. Lotrafilcon A
    5. Spectacles
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 7

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Polymacon
    2. Spectacles
    3. Galyfilcon A
    4. Lotrafilcon A
    5. Galyfilcon A Plus
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 8

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Galyfilcon A Plus
    2. Lotrafilcon A
    3. Galyfilcon A
    4. Spectacles
    5. Polymacon
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 9

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Lotrafilcon A
    2. Galyfilcon A Plus
    3. Spectacles
    4. Galyfilcon A
    5. Polymacon
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
  • Sequence 10

    Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

    1. Spectacles
    2. Polymacon
    3. Lotrafilcon A
    4. Galyfilcon A
    5. Galyfilcon A Plus
    Interventions:
    • Device: galyfilcon A
    • Device: galyfilcon A plus
    • Device: lotrafilcon A
    • Device: polymacon
    • Other: spectacles
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Not Provided
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be of legal age (i.e. 18 years)
  • Be of Asian descent and have ―Asian eye‖ identifying features (see Appendix A)
  • Be mentally competent, willing and able to sign a written informed consent form.
  • Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
  • Have spectacle astigmatism <1.25D in each eye
  • Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
  • Have had an oculo-visual examination within the previous 12 months.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No evidence of lid abnormality or infection
    • No conjunctival abnormality or infection
    • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
    • No other active ocular disease

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Has had refractive surgery.
  • Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
  • History of abnormal lachrymal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Extended lens wear in last 3 months.
  • PMMA, hybrid or RGP lens wear in the previous 8 weeks
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Has diabetes
  • Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of chronic eye disease (e.g. glaucoma or ARMD).
  • Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial or in last 30 days.
  • Family member or employee of the clinical site, investigator or other study staff.
  • Currently wears habitual contact lenses on an EW basis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01482819
CR-005031
No
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP