Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000820303
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
5/06/2017
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of two similar prototype lens designs made from different lens material.
Scientific title
Prospective, double-masked, randomized, crossover, bilateral wear dispensing clinical trial to assess visual performance of optically similar contact lens designs utilising higher-order spherical aberrations to increase depth-of-focus when manufactured in different contact lens material.
Secondary ID [1] 292096 0
None
Universal Trial Number (UTN)
Trial acronym
The SEED Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 303517 0
Condition category
Condition code
Eye 302929 302929 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomised, double-masked, cross-over clinical trial.
Participants will wear two lens designs for 5 consecutive days on a single-use, daily wear basis with a minimum two
day wash-out between lens types. The two lens designs will be optically similar and only differ in the contact lens material from which they are made. The parameters and power ranges for both lens will also be the same (base curve = 8.4 mm, diameter = 14 mm, power range = -0.75 to -6.00 D).
The two lens materials are etafilcon A and SEED 1dayPure.
Minimum wearing time will be 5 days and 6 hours/day with no maximum wearing time provided lenses
are not slept in overnight.
There will 5 visits comprising Baseline and two visits for each of the 2 lens designs (Fitting and
Assessment).
Fitting visits will be performed by unmasked investigators and comprise contact lens fitting, assessment
of contact lens visual acuity and assessment of contact lenses on eye with a slit-lamp biomicroscope (a
specialized microscope for viewing the eye). Each visit will be approximately 45 minutes in duration.
Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye).
Assessment visits will be performed by masked investigators and comprise assessment of contact
lens visual acuity and subjective ratings of vision questionnaire utilizing a 1-10 numeric rating scale.
syndrome Questionnaire.
In between Fitting and Assessment visits, participants will complete a subjective ratings of vision take home questionnaire utilizing a 1-10 numeric rating scale.
A minimum 2-day wash-out will be observed between Fitting and Assessment visits where study lenses
are not worn. Participants will wear their habitual vision correction in between wearing study lenses
All contact lenses will be prescribed and all assessments will be carried out by an optometrist.
Participants will be instructed to return all unused contact lenses.
Intervention code [1] 298238 0
Treatment: Devices
Comparator / control treatment
Contact lens made from etafilcon A.
Control group
Active

Outcomes
Primary outcome [1] 302321 0
This will be assessed using electronic logMAR charts at 6 m, 50 cm and 40 cm.
Timepoint [1] 302321 0
Both assessment visits
Secondary outcome [1] 335484 0
Subjective ratings of vision: These will be assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) which assess clarity of vision and ghosing at distance, intermediate and near, vision when driving during day time and night time and overall vision satisfaction.
Timepoint [1] 335484 0
Both midpoints between Fitting and Assessment visits
Secondary outcome [2] 335486 0
Subjective ratings of vision: These will be assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) which assess clarity of vision and ghosing at distance, intermediate and near, vision when driving during day time and night time and overall vision satisfaction.
Timepoint [2] 335486 0
Both Assessment Visits

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be presbyopic and at least 40 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 suitable and willing to wear contact lenses.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
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.
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.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created through www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
14/03/2018
Date of last participant enrolment
Anticipated
31/10/2017
Actual
26/04/2018
Date of last data collection
Anticipated
21/11/2017
Actual
1/06/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296627 0
Other
Name [1] 296627 0
Brien Holden Vision Institute
Country [1] 296627 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 295591 0
None
Name [1] 295591 0
Address [1] 295591 0
Country [1] 295591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297859 0
Bellberry Limited
Ethics committee address [1] 297859 0
Ethics committee country [1] 297859 0
Australia
Date submitted for ethics approval [1] 297859 0
15/06/2017
Approval date [1] 297859 0
27/06/2017
Ethics approval number [1] 297859 0
207-06-421

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

Contacts
Principal investigator
Name 75290 0
Mr Daniel Tilia
Address 75290 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75290 0
Australia
Phone 75290 0
+61293857516
Fax 75290 0
+61293857401
Email 75290 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 75291 0
Daniel Tilia
Address 75291 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75291 0
Australia
Phone 75291 0
+61293857516
Fax 75291 0
+61293857401
Email 75291 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 75292 0
Daniel Tilia
Address 75292 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75292 0
Australia
Phone 75292 0
+61293857516
Fax 75292 0
+61293857401
Email 75292 0
d.tilia@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
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Documents added automatically
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