Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
Status
Completed
Conditions
Myopia
Treatments
Device: galyfilcon A plus
Device: lotrafilcon A
Other: spectacles
Device: galyfilcon A
Device: polymacon
Details and patient eligibility
About
The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.
Enrollment
21 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Single Blind
21 participants in 10 patient groups
Sequence 1
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 2
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 3
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 4
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 5
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 6
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 7
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 8
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 9
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Sequence 10
Other group
Description:
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
Treatment:
Device: galyfilcon A plus
Device: polymacon
Other: spectacles
Device: galyfilcon A
Device: lotrafilcon A
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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