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Trial registered on ANZCTR


Registration number
ACTRN12611001004954
Ethics application status
Approved
Date submitted
19/09/2011
Date registered
20/09/2011
Date last updated
23/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Accommodative Lag with Multifocal Contact Lenses
Scientific title
A prospective, single-masked [participant only], multiple group, randomised clinical trial to compare the accommodative lag response and adaptataion obtained with different contact lens designs, where a minimum of sixty participants will wear three of four differently designed contact lenses bilaterally.
Secondary ID [1] 263069 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accommodative lag response 270807 0
Condition category
Condition code
Eye 270997 270997 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lotrafilcon B/ Asheric multifocal design contact lenses
Balafilcon A/ Asheric multifocal design contact lenses
Omafilcon A/Asheric multifocal design contact lenses

These lenses will be randomised to be worn for 8 days for each lens type. 4 visits (Baseline/Dispensing, interim visit 1 and 2 , Day 8 visit )are required for each lens type within the 8 day of lens wear. Minimum of 5 days of wash out period is required between different stages.
Intervention code [1] 269402 0
Treatment: Devices
Comparator / control treatment
Lotrafilcon B single vision spherical contact lenses will be worn for 8 days

4 visits (Baseline/Dispensing, interim visit 1 and 2 , Day 8 visit )are required for each lens type within the 8 day of lens wear. Minimum of 5 days of wash out period is required between different stages.
Control group
Active

Outcomes
Primary outcome [1] 279660 0
To compare the accommodative lag response and adaptation obtained with different contact lens designs.
Timepoint [1] 279660 0
Accommodative response measurements with a non-invasive novel peripheral refraction instrument will be carried out at all four visits of each stage (total 3 stages)
Secondary outcome [1] 294151 0
To compare subjective vision experience with different contact lens designs.
To compare the higher order aberration profiles obtained with different contact lens designs.
To compare peripheral refraction profiles with different contact lens designs.
Timepoint [1] 294151 0
Subjective vision/comfort questionnaire, aberration profile measures, and peripheral refraction will be carried out at all four visits of each stage (total 3 stages)

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be between the ages of 18 to 25 years of age, 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.
Have a contact lens prescription that is myopic between -1.00 and -4.00D (inclusive).
Have astigmatism that is not greater than -0.75DC and anisometropia between the two eyes of 1.00D or less.
Is correctable to at least 6/9 (20/30) or better in each eye with contact lenses.
Be an experienced and habitual contact lens wearer.
Be able to insert and remove contact lenses.
Minimum age
18 Years
Maximum age
25 Years
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.
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
Pregnancy.

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)
The planned number of participants is a minimum of 60. Enrolment will take place over approximately two months.

Participants will be screened for general clinical trial suitability by way of a routine eye examination which includes refraction, visual acuity and general eye health. Informed consent will be obtained prior to any clinical trial procedures.

The order of administering the various contact lens designs will be randomised for all participants. Study participants will be randomised into either group 1 or group 2. Within each of these groups, the order of administering the three lens types will be randomised using a cross over design.Concealed allocation will be by way of central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Particpants will be randomly asigned to two groups and the order of lens types to be worn. Randomisation plan will be generated from http://www.radomiation .com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Bilateral lens wear
Phase
Not Applicable
Type of endpoint(s)
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] 269892 0
Charities/Societies/Foundations
Name [1] 269892 0
Brien Holden Vision Institute
Address [1] 269892 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country [1] 269892 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 268905 0
None
Name [1] 268905 0
Address [1] 268905 0
Country [1] 268905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271863 0
Bellberry Limited
Ethics committee address [1] 271863 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 271863 0
Australia
Date submitted for ethics approval [1] 271863 0
Approval date [1] 271863 0
15/09/2011
Ethics approval number [1] 271863 0
2011-07-357

Summary
Brief summary
The aim of this study is to compare the accommodative lag response and accomodative adapation obatianed with different contact lens designs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33166 0
Address 33166 0
Country 33166 0
Phone 33166 0
Fax 33166 0
Email 33166 0
Contact person for public queries
Name 16413 0
Jerome Ozkan
Address 16413 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 16413 0
Australia
Phone 16413 0
+61 2 9585 7516
Fax 16413 0
Email 16413 0
j.ozkan@brienholdenvision.org
Contact person for scientific queries
Name 7341 0
Ravi Bakaraju
Address 7341 0
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 7341 0
Australia
Phone 7341 0
+61 2 9385 7516
Fax 7341 0
Email 7341 0
r.bakaraju@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