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Trial registered on ANZCTR


Registration number
ACTRN12618001201268
Ethics application status
Approved
Date submitted
7/06/2018
Date registered
18/07/2018
Date last updated
10/12/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of two contact lenses to correct presbyopia
Scientific title
Prospective, double-masked, randomized, crossover, bilateral wear dispensing clinical trial to assess visual performance of contact lens designs utilising higher-order spherical aberrations to increase depth-of-focus (EDOF) against a commercially-available multifocal contact lens
Secondary ID [1] 295138 0
None
Universal Trial Number (UTN)
Trial acronym
The SEED EDOF Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 308237 0
Condition category
Condition code
Eye 307263 307263 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial.
Participants will wear two contact lens designs for one month each on a single-use, daily wear basis with a minimum two day wash-out between lens types. Both lens types are designed to correct presbyopia. The materials and parameters for each lens type are: nelfilcon A, base curve = 8.7 mm, diameter = 14.0 mm, power range = +3.00 to -6.00 (low / med / high). SEED 1day PureMoisture: base curve = 8.8 mm, diameter = 14.2 mm, power range = +3.00 to -6.00 (low / mid / high).

The minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn, with no maximum wearing time provided lenses are not slept in overnight.

There will 7 visits comprising Baseline and three visits for each of the two lens designs (Fitting and two Assessment visits).

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. A minimum 2-day wash-out will be observed between lens designs 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 bring all unused contact lenses to each of the two Assessment visits. Compliance will be assessed by comparing the number of lenses dispensed to the number of unused lenses, as well as verbal questioning of the participant.
Intervention code [1] 301465 0
Treatment: Devices
Comparator / control treatment
Multifocal contact lenses made from nelfilcon A
Control group
Active

Outcomes
Primary outcome [1] 306212 0
Visual acuity as measured on electronic logMAR charts at 6 m, 70 cm, 50 cm ,40 cm
Timepoint [1] 306212 0
1 week: 1 week after Lens Fitting Visit 1
1 month: 1 month after Lens Fitting Visit 1- primary timepoint
5 weeks: 1 Week after Lens Fitting Visit 2
2 months: 1 month after Lens Fitting Visit 2- primary timepoint
Secondary outcome [1] 347896 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.
Questionnaires used are not validated but have been published on numerous occasions, including:
Bakaraju RC, Tilia D, Sha J, et al. Extended Depth of Focus Contact Lenses Vs. Two Commercial Multifocals: Part 2 Visual Performance after 1 Week of Lens Wear. J Optom 2017;Epub ahead of print.
Sha J, Bakaraju RC, Tilia D, et al. Short-Term Visual Performance of Soft Multifocal Contact Lenses for Presbyopia. Arq Bras Oftalmol 2016;79:73-7.
Sha J, Tilia D, Kho D, et al. Comparison of Extended Depth-of-Focus Prototype Contact Lenses with the 1-Day Acuvue Moist Multifocal after One Week of Wear. Eye Contact Lens 2017;Epub ahead of print.
Tilia D, Bakaraju RC, Chung J, et al. Short-Term Visual Performance of Novel Extended Depth-of-Focus Contact Lenses. Optom Vis Sci 2016;93:435-44.
Tilia D, Munro A, Chung J, et al. Short-Term Comparison between Extended Depth-of-Focus Prototype Contact Lenses and a Commercially-Available Center-near Multifocal. J Optom 2017;10:14-25.
Fedtke C, Bakaraju RC, Ehrmann K, et al. Visual Performance of Single Vision and Multifocal Contact Lenses in Non-Presbyopic Myopic Eyes. Cont Lens Anterior Eye 2016;39:38-46.
Timepoint [1] 347896 0
1 Week after Lens Fitting Visit 1
1 month after Lens Fitting Visit 1
1 Week after Lens Fitting Visit 2
1 month after Lens Fitting Visit 2
Secondary outcome [2] 347897 0
Graded measures of corneal staining. This will be assessed with a slit-lamp bio-microscope (specialised microscope) with a cobalt filter after the topical instillation of sodium fluorescein. Grade will occir on 0-4 scale in 0.5 steps
Timepoint [2] 347897 0
1 Week after Lens Fitting Visit 1
1 month after Lens Fitting Visit 1
1 Week after Lens Fitting Visit 2
1 month after Lens Fitting Visit 2

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2018
Actual
29/08/2018
Date of last participant enrolment
Anticipated
8/10/2018
Actual
4/10/2018
Date of last data collection
Anticipated
7/12/2018
Actual
7/12/2018
Sample size
Target
45
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299730 0
Commercial sector/Industry
Name [1] 299730 0
SEED Co., Ltd.
Country [1] 299730 0
Japan
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 299065 0
Commercial sector/Industry
Name [1] 299065 0
SEED Co., Ltd.
Address [1] 299065 0
2-40-2 Hongo, Bunkyo-ku,
Tokyo 113-8402,
Japan.
Country [1] 299065 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300620 0
Bellberry Limited
Ethics committee address [1] 300620 0
Ethics committee country [1] 300620 0
Australia
Date submitted for ethics approval [1] 300620 0
16/05/2018
Approval date [1] 300620 0
05/07/2018
Ethics approval number [1] 300620 0
2018-05-350

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

Contacts
Principal investigator
Name 84238 0
Mr Daniel Tilia
Address 84238 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW 2052
Country 84238 0
Australia
Phone 84238 0
+61293857516
Fax 84238 0
+61293857401
Email 84238 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 84239 0
Daniel Tilia
Address 84239 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW 2052
Country 84239 0
Australia
Phone 84239 0
+61293857516
Fax 84239 0
+61293857401
Email 84239 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 84240 0
Daniel Tilia
Address 84240 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW 2052
Country 84240 0
Australia
Phone 84240 0
+61293857516
Fax 84240 0
+61293857401
Email 84240 0
d.tilia@brienholdenvision.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not published. However trial results, recorded as group means plus/minus SD and their statistical analysis may be published in scientific journals.


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.