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
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: 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 July 20, 2014