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Trial registered on ANZCTR


Registration number
ACTRN12618000039280
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
12/01/2018
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial where 120 participants will wear one of three contact lenses (SEED Pure, CooperVision Proclear or Johnson & Johnson Vita), for three months with monthly replacement to determine clinical performance.
Scientific title
A prospective, randomised, open-label, bilateral wear, parallel-group, dispensing clinical trial to compare the clinical performance of SEED ionic bond (SIB) contact lens material against two commercially-available lens materials when worn for three months daily-wear with monthly replacement, and compare the clinical performance of SIB contact lens material after two weeks and one month of wear.
Secondary ID [1] 293548 0
CRTC2017-01
Universal Trial Number (UTN)
Trial acronym
The SIB Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 305768 0
Condition category
Condition code
Eye 304991 304991 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, open-label clinical trial. Participants will wear one of three lens types for three months with monthly replacement daily wear basis in conjunction with OPTI-FREE Puremoist multipurpose disinfecting solution. The three lens types comprise:
Commercially-available (Europe and Japan) single vision lenses manufactured by SEED and made from SEED ionic bond (SIB) material: Base curve: 8.6 mm, Diameter: 14.2 mm, Power Range: -0.75 to -6.00 D.
Commercially-available (Australia) lenses single vision lenses manufactured by Johnson & Johnson and made from senofilcon C material: Base curve: 8.4 mm, Diameter: 14 mm, Power Range: -0.75 to -6.00 D.
Commercially-available (Australia) lenses single vision lenses manufactured by CooperVision and made from omafilcon A material: Base curve: 8.6 mm, Diameter: 14 mm, Power Range: -0.75 to -6.00 D.
At each visit, investigators will ensure that participants have one pair of lenses to wear and one spare pair of lenses.
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 5 visits comprising Baseline and four follow-up visits at 2-weeks, 1-month, 2-months, 3-months after Baseline. Each visit will be approximately 45 minutes in duration.
Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement, ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye, lens fitting, lens assessment with slit-lamp biomicroscope and questionnaire (see below).
All assessment visits will comprise questionnaires (see below), visual acuity measurement and lens and ocular assessment with slit-lamp biomicroscope.
Questionnaires will be completed at all visits, and will utilise numeric rating scales (1-10 in 1-point steps) and 6-point Likert scales.
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 not commercially-available in Australia.
Intervention code [1] 299796 0
Treatment: Devices
Comparator / control treatment
Active controls: single vision omafilcon A and senofilcon C lenses.
Control group
Active

Outcomes
Primary outcome [1] 304158 0
Subjective rating of comfort with contact lenses as assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) .
Timepoint [1] 304158 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Primary outcome [2] 304232 0
Subjective rating of clarity of vision with contact lenses as assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) .
Timepoint [2] 304232 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Primary outcome [3] 304233 0
Subjective rating of lens handling with contact lenses as assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps).
Timepoint [3] 304233 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [1] 341109 0
Visual acuity. This will be assessed at 6 m using standard logMAR charts under photopic conditions.
Timepoint [1] 341109 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [2] 341110 0
Subjective assessment of comfort with contact lenses as assessed with a questionnaire utilising a 6-point Likert scale.
Timepoint [2] 341110 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [3] 341111 0
Lens wettability as assessed with a slit-lamp biomicroscope and graded on a 0-4 scale.
Timepoint [3] 341111 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [4] 341112 0
Ocular redness as assessed with a slit-lamp biomicroscope and graded on a 0-4 scale.
Timepoint [4] 341112 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [5] 341320 0
Subjective assessment of vision with contact lenses as assessed with a questionnaire utilising a 6-point Likert scale.
Timepoint [5] 341320 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [6] 341321 0
Subjective assessment of lens handling with contact lenses as assessed with a questionnaire utilising a 6-point Likert scale.
Timepoint [6] 341321 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [7] 341322 0
Lens deposition as assessed with a slit-lamp biomicroscope and graded on a 0-4 scale.
Timepoint [7] 341322 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [8] 341323 0
Ocular roughnesss as assessed with a slit-lamp biomicroscope and graded on a 0-4 scale.
Timepoint [8] 341323 0
Baseline, 2 weeks, 1 month, 2 months, 3 months
Secondary outcome [9] 341324 0
Ocular fluorescein staining as assessed with a slit-lamp biomicroscope and graded on a 0-4 scale.
Timepoint [9] 341324 0
Baseline, 2 weeks, 1 month, 2 months, 3 months

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.
Is correctable to at least 6/7.5 (20/25) or better in each eye with best-corrected subjective refraction and 6/12 (20/40) or better in each eye with contact lenses.
Can be an experienced or first time (neophyte) contact lens wearer.
Be able to insert and remove contact lenses.
Minimum age
18 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 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*.
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.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 40 participants per lens type (120 in total) are required in order to demonstrate a statistically significant group difference between lens types for visual acuity (0.1±0.15 logMAR), subjective ratings (1 +/- 1.5 rating units) and clinical grades (0.5±0.75 grade units) at the 5% level of significance and 80% power. The difference of 0.1 logMAR, 0.5 clinical grade and 1 rating units correspond to clinically significant levels. The standard deviations correspond to the largest expected SD based on similar trials done in the past. The sample size of 40 participants is adjusted for a drop out of 10%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
30/01/2018
Date of last participant enrolment
Anticipated
23/07/2018
Actual
13/06/2018
Date of last data collection
Anticipated
15/09/2018
Actual
14/09/2018
Sample size
Target
120
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298163 0
Commercial sector/Industry
Name [1] 298163 0
SEED Co., Ltd.
Country [1] 298163 0
Japan
Primary sponsor type
Other
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] 297254 0
Commercial sector/Industry
Name [1] 297254 0
SEED Co., Ltd.
Address [1] 297254 0
2-40-2 Hongo, Bunkyo-ku,
Tokyo 113-8402,
Japan.
Country [1] 297254 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299178 0
Bellberry Limited
Ethics committee address [1] 299178 0
Ethics committee country [1] 299178 0
Australia
Date submitted for ethics approval [1] 299178 0
22/11/2017
Approval date [1] 299178 0
02/01/2018
Ethics approval number [1] 299178 0

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

Contacts
Principal investigator
Name 79558 0
Mr Daniel Tilia
Address 79558 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 79558 0
Australia
Phone 79558 0
+61293857516
Fax 79558 0
+61293857401
Email 79558 0
[email protected]
Contact person for public queries
Name 79559 0
Daniel Tilia
Address 79559 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 79559 0
Australia
Phone 79559 0
+61293857516
Fax 79559 0
+61293857401
Email 79559 0
[email protected]
Contact person for scientific queries
Name 79560 0
Daniel Tilia
Address 79560 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 79560 0
Australia
Phone 79560 0
+61293857516
Fax 79560 0
+61293857401
Email 79560 0
[email protected]

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.