Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
April 30, 2015
CompletedJune 19, 2018
August 1, 2017
2 months
November 16, 2011
January 8, 2015
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Corneal Swelling
measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
after 8 hours of lens wear
Limbal Redness
grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
after 8 hours of lens wear
Endothelia Blebs
0 to 100% of area; measured as a percentage of corneal area with blebs.
after 20 minutes of lens wear
Study Arms (10)
Sequence 1
OTHERFive 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
Sequence 2
OTHERFive 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
Sequence 3
OTHERFive 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
Sequence 4
OTHERFive 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
Sequence 5
OTHERFive 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
Sequence 6
OTHERFive 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
Sequence 7
OTHERFive 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
Sequence 8
OTHERFive 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
Sequence 9
OTHERFive 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
Sequence 10
OTHERFive 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
contact lenses worn bilaterally for 8-12 hours
contact lenses worn bilaterally for 8-12 hours
contact lenses worn bilaterally for 8-12 hours
contact lenses worn bilaterally for 8-12 hours
habitual spectacles owned by subject, non-specific manufacturer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Hawthorn, Victoria, 3122, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daria Wicks, Senior Clinical Research Manager
- Organization
- Johnson & Johnson Vision Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2011
First Posted
December 1, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 19, 2018
Results First Posted
April 30, 2015
Record last verified: 2017-08