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Trial registered on ANZCTR


Registration number
ACTRN12614000011684
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
6/01/2014
Date last updated
10/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, participant-masked, bilateral wear, multiple arm, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in participants with presbyopia and/or myopia
Scientific title
Prospective, participant-masked, bilateral wear, multiple arm, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in participants with presbyopia and/or myopia
Secondary ID [1] 283745 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 290713 0
Myopia 290714 0
Condition category
Condition code
Eye 291083 291083 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear up to 6 pairs of lenses [up to 4 prototype (test) and up to 2 commercial (control)] lenses bilaterally. All 4 prototype lenses will be multifocal designs and each test lenses will have different amount of add power (+1.25, +1.50, +1.75, +2.00). Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Lenses will be worn on a daily wear basis and each lens assessment will require 2 scheduled clinic attendances – a fitting visit on Day 1 and an evaluation visit between Day 5 to Day 7 with 2 take-home questionnaires to be completed between the fitting visit and evaluation visit.
Intervention code [1] 288432 0
Treatment: Devices
Comparator / control treatment
In the presbyope group, the control contact lenses will be Air Optix Aqua Multifocal and Acuvue Oasys for Presbyopia contact lens to be worn for five days on a daily wear, single use basis. In the non-presbyope group, the controls will be Air Optix Aqua and Acuvue 1 Day Moist single vision contact lens to be worn for five days on a daily wear, single use basis.
Control group
Active

Outcomes
Primary outcome [1] 291068 0
Visual acuity will be assessed at distance and near with a computerised LogMAR chart and an MNRead Acuity chart respectively.
Timepoint [1] 291068 0
Day 1 (immediately after lens fit) and Day 5 (assessment visit)
Primary outcome [2] 291171 0
Contrast sensitivity will be measured with a computerised LogMAR chart.
Timepoint [2] 291171 0
Day 1 (immediately after lens fit) and Day 5 (assessment visit)
Secondary outcome [1] 305962 0
Subjective ratings of clarity, ghosting, overall vision satisfaction and comfort with the lenses will be assessed for each pair of lenses with a questionnaire based on a 1-10 scale.
Timepoint [1] 305962 0
Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)
Secondary outcome [2] 306179 0
Participants' willingness to purchase the lenses, identified in a questionnaire.
Timepoint [2] 306179 0
Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)
Secondary outcome [3] 306180 0
Positive and negative aspects of the lenses, identified in a questionnaire.
Timepoint [3] 306180 0
Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)

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.
Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent).
Have at least +1.00D of Add prescription for presbyopes
Have at least -0.50D of myopic prescription for myopes
Minimum age
18 Years
Maximum age
70 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, Sjogrens 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.

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 minimum number of participants is 10 for each parallel arm for both the presbyopic and non-presbyopic groups. Enrolment will take place over 6 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. Neophyte and experienced contact lens wearers will be enrolled into lens wear.
Participants will be allocated to a group, contact lens designs differ within the groups and the order of contact lens wear will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan for cross-over lens allocation (within each stratification group) will be generated from http://www.randomization.com/. The website’s second random generator will be used to create a random permutation of all lens types for each participant. The generated randomisation list will be copied from the website by the biostatistician and applied through the Clinic Data Management system.

The randomisation code will be applied (and broken if required) by a Clinical Coordinator (CC), and clearly documented. The Investigator will not have access to this randomisation code until the trial is completed and final data analysis performed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A minimum of 10 participants in each arm of both the groups (presbyope and non-presbyope) are required in order to demonstrate a statistically significant paired difference of 0.1+/-0.1 logMAR visual acuity between test and control lens types at the 5% level of significance and 80% power. The sample size within each arm is not adjusted for dropouts due to the short duration of the study. Participants will need to be replaced if drop outs occur within an arm.

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)
NSW
Recruitment postcode(s) [1] 7634 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 288416 0
Commercial sector/Industry
Name [1] 288416 0
Brien Holden Vision Pty Ltd
Address [1] 288416 0
Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country [1] 288416 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brien Holden Vision Pty Ltd
Address
Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 287123 0
None
Name [1] 287123 0
Address [1] 287123 0
Country [1] 287123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290293 0
Bellberry Limited
Ethics committee address [1] 290293 0
129 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 290293 0
Australia
Date submitted for ethics approval [1] 290293 0
31/05/2013
Approval date [1] 290293 0
11/12/2013
Ethics approval number [1] 290293 0
2013-05-211

Summary
Brief summary
To assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44902 0
Mr Daniel Tilia
Address 44902 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 44902 0
Australia
Phone 44902 0
+612 9385 6165
Fax 44902 0
+612 9385 7401
Email 44902 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 44903 0
Mr Daniel Tilia
Address 44903 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 44903 0
Australia
Phone 44903 0
+612 9385 6165
Fax 44903 0
+612 9385 7401
Email 44903 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 44904 0
Mr Daniel Tilia
Address 44904 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 44904 0
Australia
Phone 44904 0
+612 9385 6165
Fax 44904 0
+612 9385 7401
Email 44904 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