Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
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