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
  Purpose

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


Condition Intervention
Myopia
Device: galyfilcon A
Device: galyfilcon A plus
Device: lotrafilcon A
Device: polymacon
Other: spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: October 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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
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 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
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 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
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 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
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 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
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 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
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 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
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 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
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 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482819

Locations
Australia, Victoria
Hawthorn, Victoria, Australia, 3122
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01482819     History of Changes
Other Study ID Numbers: CR-005031
Study First Received: November 16, 2011
Last Updated: April 1, 2013
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014