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Trial registered on ANZCTR


Registration number
ACTRN12613001380785
Ethics application status
Approved
Date submitted
11/12/2013
Date registered
16/12/2013
Date last updated
7/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to assess the visual performance of prototype contact lenses.
Scientific title
Prospective, participant-masked, bilateral wear, crossover clinical trial to assess visual performance of multiple prototype contact lens designs compared to commercial contact lenses in presbyopes.
Secondary ID [1] 283760 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 290735 0
Condition category
Condition code
Eye 291098 291098 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The contact lenses being studied are prototype soft contact lenses made from Etafilcon A material. The lenses differ only in their power profile - all are made from the same material.

Participants will test up to 25 pairs of lenses with a minimum overnight wash-out period between each pair. Ideally, all participants would test all 25 pairs, however as they are able to withdraw at any time, the number of lenses tested is essentially determined by the participant.

Lenses will be inserted bilaterally on the participant by the investigating optometrist, and worn for a maximum of 1.5 hours.
Intervention code [1] 288448 0
Treatment: Devices
Comparator / control treatment
Participants will test up to 4 commercially available contact lenses as controls (minimum 2) with a minimum overnight wash-out period between each pair. Ideally all participants would test all 4 controls, but as they are able to withdraw at any time, some participants may not test all controls.

The control lenses are AirOptix Aqua single vision, AirOptix Aqua Multifocal, Proclear Multifocal and Acuvue Oasys for Presbyopia. Lenses will be inserted bilaterally on the participant by the investigating optometrist, and worn for a maximum of 1.5 hours.
Control group
Active

Outcomes
Primary outcome [1] 291084 0
To evaluate the visual performance of prototype contact lenses compared to commercial equivalents.

Objective measurements of high contrast visual acuity, low contrast visual acuity and contrast sensitivity will be assessed for each pair of lenses with a computerised LogMAR chart. Near visual acuity will be assessed with MNRead Acuity chart.
Timepoint [1] 291084 0
Within 1.5 hours of inserting each lens design.
Secondary outcome [1] 305984 0
Subjective responses of participants wearing the prototype contact lenses.

Subjective ratings of clarity, ghosting, overall vision satisfaction and comfort will be assessed for each pair of lenses with a questionnaire based on a 1-10 scale.
Timepoint [1] 305984 0
Within 1.5 hours of inserting each lens design.
Secondary outcome [2] 306010 0
Participants' willingness to purchase the lenses, identified in a questionnaire.
Timepoint [2] 306010 0
Within 1.5 hours of inserting each lens design
Secondary outcome [3] 306011 0
Positive and negative aspects of each prototype lens design, identified in a questionnaire.
Timepoint [3] 306011 0
Within 1.5 hours of inserting each lens design.

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 40 years old, with presbyopia (reading add of 1 Dioptre or more).
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 experienced or inexperienced at wearing contact lenses.
Minimum age
40 Years
Maximum age
70 Years
Sex
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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.

At each scheduled lens fitting visit, participants will be allocated one pair of contact lenses to correct their refractive error. Initially the single vision control lens will be tested. For the remaining scheduled visits, one pair of multifocal control or prototype contact lenses will be allocated for each lens fitting/assessment visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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 are required in order to demonstrate a statistically significant paired difference between the control lenses and each iteration in visual acuity of 0.1 +/-0.1 logMAR units at the 5% level of significance and 80% power. The minimum sample size is a requirement at each stage of the cross over trial. The sample size is not adjusted for drop outs due to the short nature of each stage.

Statistical analysis is planned to commence on completion of trial monitoring and the submission of the data analysis request form. Any interim analysis will be conducted as described in this section, unless a documented request is received from the Sponsor and approved by the trial PI.

Data stored in relational databases will be imported into PASW / SAS / STATA software for statistical purposes. Data will be investigated for quality using range checks and frequency distribution. Underlying distributions of variables will be tested. In general, variables measured on an interval scale with a sufficiently large sample size will be considered to follow a normal distribution. Outputs from the statistical analysis such as statistical tables will be copied over to Excel. Graphs will generally not be created from the statistical software. All statistical results will be reported in Excel format.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2013
Actual
22/11/2013
Date of last participant enrolment
Anticipated
Actual
23/07/2014
Date of last data collection
Anticipated
Actual
23/07/2014
Sample size
Target
150
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7640 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 288426 0
Charities/Societies/Foundations
Name [1] 288426 0
Brien Holden Vision Institute
Country [1] 288426 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Dr Ravi Bakaraju
Address
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 287131 0
None
Name [1] 287131 0
Address [1] 287131 0
Country [1] 287131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290302 0
Bellberry Limited
Ethics committee address [1] 290302 0
Ethics committee country [1] 290302 0
Australia
Date submitted for ethics approval [1] 290302 0
Approval date [1] 290302 0
28/08/2012
Ethics approval number [1] 290302 0
2012-07-967

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

Contacts
Principal investigator
Name 44954 0
Ms Pauline Xu
Address 44954 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 44954 0
Australia
Phone 44954 0
+61293857516
Fax 44954 0
Email 44954 0
p.xu@brienholdenvision.org
Contact person for public queries
Name 44955 0
Pauline Xu
Address 44955 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 44955 0
Australia
Phone 44955 0
+61293857516
Fax 44955 0
Email 44955 0
p.xu@brienholdenvision.org
Contact person for scientific queries
Name 44956 0
Pauline Xu
Address 44956 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 44956 0
Australia
Phone 44956 0
+61293857516
Fax 44956 0
Email 44956 0
p.xu@brienholdenvision.org

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.