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Trial details imported from ClinicalTrials.gov

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

1. Lotrafilcon A
2. Spectacles
3. Galyfilcon A Plus
4. Polymacon
5. 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:

1. Galyfilcon A Plus
2. Galyfilcon A
3. Lotrafilcon A
4. Polymacon
5. 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:

1. Galyfilcon A
2. Polymacon
3. Galyfilcon A Plus
4. Spectacles
5. 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:

1. Spectacles
2. Lotrafilcon A
3. Polymacon
4. Galyfilcon A Plus
5. 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:

1. Polymacon
2. Galyfilcon A
3. Spectacles
4. Galyfilcon A Plus
5. 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:

1. Galyfilcon A
2. Galyfilcon A Plus
3. Polymacon
4. Lotrafilcon A
5. 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:

1. Polymacon
2. Spectacles
3. Galyfilcon A
4. Lotrafilcon A
5. 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:

1. Galyfilcon A Plus
2. Lotrafilcon A
3. Galyfilcon A
4. Spectacles
5. 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:

1. Lotrafilcon A
2. Galyfilcon A Plus
3. Spectacles
4. Galyfilcon A
5. 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:

1. Spectacles
2. Polymacon
3. Lotrafilcon A
4. Galyfilcon A
5. 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
Timepoint [1] 0 0
after 8 hours of lens wear
Primary outcome [2] 0 0
Limbal Redness
Timepoint [2] 0 0
after 8 hours of lens wear
Primary outcome [3] 0 0
Endothelia 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
Sex
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
NA
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
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
21
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01482819