Trial Review

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/ct2/show/NCT01054807




Registration number
NCT01054807
Ethics application status
Date submitted
21/01/2010
Date registered
22/01/2010
Date last updated
19/06/2018

Titles & IDs
Public title
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
Scientific title
Secondary ID [1] 0 0
CTN# 155/2009
Secondary ID [2] 0 0
CR-0915
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 Habitual Lens
Treatment: Devices - Galyfilcon A 8.7 BC (Investigational)
Treatment: Devices - Galyfilcon A 8.3 BC (Investigational)

Other: GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 - Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)

Other: Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL - Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Other: GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7 - Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)

Other: Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3 - Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)

Other: Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7 - Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)

Other: Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL - Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)


Treatment: Devices: Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.

Treatment: Devices: Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.

Treatment: Devices: Galyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of Lens Fit Characteristics
Timepoint [1] 0 0
Approximately 40 minutes of wear time
Primary outcome [2] 0 0
Evaluation of Inter-Changeability
Timepoint [2] 0 0
Approximately 40 minutes of wear time
Primary outcome [3] 0 0
Determination of fit or Vision Differences
Timepoint [3] 0 0
Approximately 40 minutes of wear time

Eligibility
Key inclusion criteria
- Be of legal age (i.e., at least 18 years old)

- Sign a written informed consent

- Have contact lens distance sphere requirement in the range -1.00D to -6.00D

- Have spectacle astigmatism <1.25D in each eye

- Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current
prescription.

- Have normal eyes with no evidence of abnormality or disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Required concurrent ocular medication

- Any systemic illness which would contra-indicate lens wear or the medical treatment of
which would affect vision or successful lens wear.

- Eye injury or surgery within eight weeks immediately prior to enrollment for this
study.

- Abnormal lacrimal secretions

- Pre-existing ocular irritation that would preclude contact lens fitting.

- Keratoconus or other corneal irregularity.

- Pregnancy, lactating or planning a pregnancy at the time of enrolment.

- Participation in any concurrent clinical trial

- Known allergy to silver, silver ions, or silver containing compounds.

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


The people analysing the results/data
Intervention assignment
Crossover
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
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Coles-Brennan Pty Ltd - 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
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Coles-Brennan Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this investigation is to compare the fit characteristics and vision attributes
of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01054807
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Noel Brennan, McOptom PhD
Address 0 0
Coles-Brennan Pty Ltd
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01054807