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Trial registered on ANZCTR


Registration number
ACTRN12610000001099
Ethics application status
Approved
Date submitted
18/12/2009
Date registered
4/01/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Daily disposable trial:Prospective, open label, randomised, cross-over clinical trial to evaluate the performance of Focus (registered trademark) 1-2 Week, Focus(registered trademark) Monthly and FreshLook (registered trademark) Handling Tint contact lenses on a daily wear, daily disposable wear schedule in neophyte and experienced East Asian wearers.
Scientific title
Prospective, open label, randomised, cross-over clinical trial to evaluate the performance of Focus (registered trademark) 1-2 Week, Focus (registered trademark) Monthly and FreshLook(registered trademark) Handling Tint contact lenses on a daily wear, daily disposable wear schedule in neophyte and experienced East Asian wearers.
Secondary ID [1] 1217 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluation of the vision, fitting characteristics, ocular and subjective responses of commercially available lenses made from Vifilcon A (Focus 1-2 Week, Focus Monthly) and Phemfilcon A (Freshlook Handling Tint). 256428 0
Condition category
Condition code
Eye 256601 256601 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, open label, randomised, crossover trial to assess the performance of contact lenses made from vifilcon A and phemfilcon A when worn for 1 month each over a 3 month period (with 1 day washout between switching lenses) on a daily wear, daily disposable schedule.
Intervention code [1] 255724 0
Treatment: Devices
Comparator / control treatment
Acrive control - crossover study
Control group
Active

Outcomes
Primary outcome [1] 257491 0
To determine the best performing lens in terms of clinical (vision, fitting characteristics, ocular responses) and subjective responses. Clinical responses will be assessed with medical equipment (vision chart and biomicroscope) and subjective responses with questionnaires.
Timepoint [1] 257491 0
Baseline, 1, 2 and 3 months
Secondary outcome [1] 262700 0
Nil
Timepoint [1] 262700 0
Nil

Eligibility
Key inclusion criteria
-Be 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;
-Be of East Asian ethnicity (either Japanese, Chinese, Taiwanese or Korean);
-Be 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;
-Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
-Be experienced or may be inexperienced at wearing contact lenses.
-Have a current spectacle correction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
-An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
-Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
-Use of or a need for any systemic medication or topical medications or participation in any clinical trial which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
-Previous corneal refractive surgery;
-Contraindications to contact lens wear;
-Contact lens wear within 1 calendar day of initial lens fitting (washout period to be performed post enrolment if necessary)
-Allergy or intolerance to topical anaesthetics

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)
Subjects will be randomly allocated (allocation concealment performed by central randomisation by computer) to wear each lens type (Focus 1-2 week, Focus Monthly and Freshlook Handling tint) for 1 month each over a 3 month period. The person who determined if a subject was eligible for inclusion in the trial was unaware as to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list (which will be generated by computer) will be generated based on a crossover design where each subject receives all the study products.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256198 0
Commercial sector/Industry
Name [1] 256198 0
CIBA VISION
Country [1] 256198 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CIBA VISION
Address
11460 Johns Creek Parkway
Duluth, GA 30097-1556
Country
United States of America
Secondary sponsor category [1] 251540 0
None
Name [1] 251540 0
Address [1] 251540 0
Country [1] 251540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258300 0
Vision Cooperative Research Centre (CRC) and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 258300 0
Ethics committee country [1] 258300 0
Australia
Date submitted for ethics approval [1] 258300 0
Approval date [1] 258300 0
16/12/2009
Ethics approval number [1] 258300 0
09/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30635 0
Address 30635 0
Country 30635 0
Phone 30635 0
Fax 30635 0
Email 30635 0
Contact person for public queries
Name 13882 0
Jerome Ozkan
Address 13882 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street,
UNSW Sydney NSW 2052
Country 13882 0
Australia
Phone 13882 0
+6193857516
Fax 13882 0
+6193857401
Email 13882 0
[email protected]
Contact person for scientific queries
Name 4810 0
Percy Lazon
Address 4810 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street,
UNSW Sydney NSW 2052
Country 4810 0
Australia
Phone 4810 0
+6193857516
Fax 4810 0
+6193857401
Email 4810 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.