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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01482819




Registration number
NCT01482819
Ethics application status
Date submitted
16/11/2011
Date registered
1/12/2011
Date last updated
19/06/2018

Titles & IDs
Public title
Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
Scientific title
Secondary ID [1] 0 0
CR-005031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - galyfilcon A
Treatment: Devices - galyfilcon A plus
Treatment: Devices - lotrafilcon A
Treatment: Devices - polymacon
Other interventions - spectacles

Other: 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:
Lotrafilcon A
Spectacles
Galyfilcon A Plus
Polymacon
Galyfilcon A

Other: 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:
Galyfilcon A Plus
Galyfilcon A
Lotrafilcon A
Polymacon
Spectacles

Other: 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:
Galyfilcon A
Polymacon
Galyfilcon A Plus
Spectacles
Lotrafilcon A

Other: 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:
Spectacles
Lotrafilcon A
Polymacon
Galyfilcon A Plus
Galyfilcon A

Other: 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:
Polymacon
Galyfilcon A
Spectacles
Galyfilcon A Plus
Lotrafilcon A

Other: 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:
Galyfilcon A
Galyfilcon A Plus
Polymacon
Lotrafilcon A
Spectacles

Other: 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:
Polymacon
Spectacles
Galyfilcon A
Lotrafilcon A
Galyfilcon A Plus

Other: 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:
Galyfilcon A Plus
Lotrafilcon A
Galyfilcon A
Spectacles
Polymacon

Other: 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:
Lotrafilcon A
Galyfilcon A Plus
Spectacles
Galyfilcon A
Polymacon

Other: 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:
Spectacles
Polymacon
Lotrafilcon A
Galyfilcon A
Galyfilcon A Plus


Treatment: Devices: galyfilcon A
contact lenses worn bilaterally for 8-12 hours

Treatment: Devices: galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours

Treatment: Devices: lotrafilcon A
contact lenses worn bilaterally for 8-12 hours

Treatment: Devices: polymacon
contact lenses worn bilaterally for 8-12 hours

Other interventions: spectacles
habitual spectacles owned by subject, non-specific manufacturer

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
after 8 hours of lens wear
Primary outcome [2] 0 0
Limbal Redness - grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Timepoint [2] 0 0
after 8 hours of lens wear
Primary outcome [3] 0 0
Endothelia Blebs - 0 to 100% of area; measured as a percentage of corneal area with blebs.
Timepoint [3] 0 0
after 20 minutes of lens wear

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Vision Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01482819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications