Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
NCT ID: NCT01482819
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2011-10-01
2011-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
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
galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
spectacles
habitual spectacles owned by subject, non-specific manufacturer
Interventions
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galyfilcon A
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
polymacon
contact lenses worn bilaterally for 8-12 hours
spectacles
habitual spectacles owned by subject, non-specific manufacturer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Hawthorn, Victoria, Australia
Countries
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Other Identifiers
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CR-005031
Identifier Type: -
Identifier Source: org_study_id
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