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Trial registered on ANZCTR


Registration number
ACTRN12612000487819
Ethics application status
Approved
Date submitted
2/05/2012
Date registered
3/05/2012
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Topaz investigational multi-purpose solution when used with two types of contact lenses
Scientific title
A prospective, bilateral, open-label, parallel group, randomised clinical trial to compare Topaz investigational multi-purpose solution and two commercially available solutions for subjective response, lens deposition and ocular surface effects when used in conjunction with two types of contact lenses in experienced wearers.
Secondary ID [1] 280430 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective response to different types of contact lens solutions 286399 0
Lens deposition 286400 0
Ocular surface effects 286401 0
Condition category
Condition code
Eye 286653 286653 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, open label clinical trial with two parallel groups of 40 participants each, randomised to ACUVUE [Registered trade mark] OASYS [Trademark] or ACUVUE [Registered trade mark] 2 lenses worn bilaterally for one month on a daily-wear basis (n=80 in total). Each lens-group will be, randomised to COMPLETE [Registered trade mark] Multi-Purpose Solution Easy Rub [Trademark] Formula or renu [Registered trade mark] fresh [Trademark] for the first month of the trial only (n=20 in each solution / lens combination). After the first month of lens wear, all participants will be crossed over into Topaz multipurpose solution, whilst continuing wear of the same lens type. Lenses will be worn on a daily-wear basis for a further three months. There will be four scheduled visits: baseline, 1-month visit, 2-month visit, 4-month visit.
These visits will involve assessment of visual acuity, assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale and ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye) . Lenses will be worn
a minimum of 5 days per week, 6 hours per day.
All solutions will be used after lens removal and as per manufacturer’s recommendation: Rub lenses with solution (5 seconds), rinse lenses with solution (5seconds) and store in solutionfor at least 6 hours. Solution is not to be reused.
Contact lenses will be replaced 2x/month.
Intervention code [1] 284790 0
Treatment: Devices
Comparator / control treatment
The two commercially available solutions will serve as controls and Topaz will be the test.
Control group
Active

Outcomes
Primary outcome [1] 287056 0
Ocular comfort as measured with 1-10 numeric rating scales
Timepoint [1] 287056 0
At baseline and after 1 month, 2 months and 4 months of wear
Secondary outcome [1] 297277 0
Ocular surface effetcs as assessed with a slit lamp biomicroscope, which is a specialised microscope to view the eye
Timepoint [1] 297277 0
At baseline and after 1 month, 2 months and 4 months of wear
Secondary outcome [2] 297278 0
Lens deposition as assessed ex vivo with a microscope
Timepoint [2] 297278 0
After 1 month and 2 months of wear

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old, male or female.
Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
Have ocular health findings considered to be “normal” and which would not prevent the Participant from safely wearing contact lenses.
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be an experienced contact lens wearer
Be able to insert and remove contact lenses.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective Participants.
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a Participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Neophytes (potential Participants who have not previously worn contact lenses).
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
Pregnancy*.
The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the Participant’s best interests.
*Formal testing of pregnancy is not required. A Participant’s verbal report is sufficient.

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)
Participants who satisfy the inclusion/exclusion criteria are enrolled in the trial and are given a sequential participant number. A randomisation plan (see below) is used to allocate contact lens type (and solution) to each participant, based on their unique participant number. A randomisation list will be generated by the biostatistician and applied through the Clinic Data Management system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated from http://www.randomization.com/.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 285190 0
Charities/Societies/Foundations
Name [1] 285190 0
Brien Holden Vision Institute
Address [1] 285190 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country [1] 285190 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Optics, Inc
Address
1700 East St. Andrew Place
PO Box 25162 Santa Ana, CA 92799-5162
Country
United States of America
Secondary sponsor category [1] 284058 0
None
Name [1] 284058 0
Address [1] 284058 0
Country [1] 284058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287196 0
Bellberry Limited
Ethics committee address [1] 287196 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 287196 0
Australia
Date submitted for ethics approval [1] 287196 0
03/05/2012
Approval date [1] 287196 0
04/06/2012
Ethics approval number [1] 287196 0

Summary
Brief summary
This trial will examine the effect of a new
solution on subjective response, the ocular surface, and lens deposition. The hypotheses are these outcomes will be similar for each lens type and similar for control solutions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34130 0
Mr Daniel Tilia
Address 34130 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 34130 0
Australia
Phone 34130 0
+61293857516
Fax 34130 0
Email 34130 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 17377 0
Mr Daniel Tilia
Address 17377 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 17377 0
Australia
Phone 17377 0
+61293857516
Fax 17377 0
Email 17377 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 8305 0
Mr Daniel Tilia
Address 8305 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 8305 0
Australia
Phone 8305 0
+61293857516
Fax 8305 0
Email 8305 0
d.tilia@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary