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Trial registered on ANZCTR


Registration number
ACTRN12615000285550
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
26/03/2015
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of two contact lenses in experienced lens wearers to determine differences in lens comfort and lens clinical performance when lenses are each worn for two weeks
Scientific title
A prospective, bilateral, randomised, double-masked, cross-over clinical trial to compare the clinical performance of formofilcon B silicone hydrogel daily disposable lenses against somofilcon A silicone hydrogel daily disposable lenses when worn for 2 weeks on a daily wear basis by experienced lens wearers
Secondary ID [1] 286362 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective comfort of contact lenses 294499 0
Ocular surface response to contact lenses 294500 0
Condition category
Condition code
Eye 294802 294802 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomised, double-masked, cross-over masked clinical trial. Participants will wear two lens typfor two weeks on a single-use, daily wear basis with a minimum two day wash-out between lens types. The lens types are formofilcon B and somofilcon A. Both lens types are classified as silicone-hydrogel material with water contents of 48% and 56% respectively. Lenses will be power-matched for each participant. Minimum wearing time will be 5 days/week and 6 hours/day. There is no maximum wearing time provided lenses are not slept in overnight. There will five visits: Baseline, Stage 1: lens fit, Stage 1: 2-week visit, Stage 2: lens fit, Stage 2: 2-week visit. These visits will involve assessment of visual acuity, assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale and ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye). All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to return all used lens packets and any unused contact lenses.
Intervention code [1] 291423 0
Treatment: Devices
Comparator / control treatment
Active control (somofilcon A) - cross over study
Control group
Active

Outcomes
Primary outcome [1] 294552 0
Ocular comfort while wearing contact lenses, assessed by questionnaire specifically designed for this study
Timepoint [1] 294552 0
Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit
Primary outcome [2] 294604 0
Ocular dryness while wearing contact lenses, assessed by questionnaire specifically designed for this study
Timepoint [2] 294604 0
Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit
Primary outcome [3] 294605 0
Subjective vision while wearing contact lenses, assessed by questionnaire specifically designed for this study
Timepoint [3] 294605 0
Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit
Secondary outcome [1] 313609 0
Corneal staining while wearing contact lenses, assessed with slit-lamp biomicroscopy and graded using the Brien Holden Vision Institute grading scale
Timepoint [1] 313609 0
Baseline, Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit
Secondary outcome [2] 313705 0
Bulbar hyperaemia while wearing contact lenses, assessed with slit-lamp biomicroscopy and graded using the Brien Holden Vision Institute grading scale
Timepoint [2] 313705 0
Baseline, Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit
Secondary outcome [3] 313706 0
Limbal hyperaemia while wearing contact lenses, assessed with slit-lamp biomicroscopy and graded using the Brien Holden Vision Institute grading scale
Timepoint [3] 313706 0
Baseline, Stage 1: Fitting, Stage 1: 2-week visit, Stage 2: Fitting, Stage 2: 2-week visit

Eligibility
Key inclusion criteria
Be 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.
Be 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.
Be correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be an experienced lens wearer.
Be able to insert and remove contact lenses
Minimum age
18 Years
Maximum age
No limit
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, Sjögrens 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. However, such ocular medications can be prescribed as per standard optometric care 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.
Pregnancy: (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient).

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)
Participants who satisfy the inclusion/exclusion criteria are enrolled in the trial. A participant is considered “successfully enrolled” when the Investigator agrees that they conform to the inclusion / exclusion criteria, and on successful fit of clinical trial products.
The order in which lenses are worn will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated from http://www.randomization.com/. The website’s second random generator will be used to create a block random permutation of the two lens types within 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 for solution 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
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 290932 0
Other
Name [1] 290932 0
Brien Holden Vision Institute
Address [1] 290932 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country [1] 290932 0
Australia
Funding source category [2] 290933 0
Commercial sector/Industry
Name [2] 290933 0
Pegavision
Address [2] 290933 0
No.5, Shing Yeh St., Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan (R.O.C.)
Country [2] 290933 0
Taiwan, Province Of China
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 289618 0
None
Name [1] 289618 0
Address [1] 289618 0
Country [1] 289618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292539 0
Bellberry Limited
Ethics committee address [1] 292539 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 292539 0
Australia
Date submitted for ethics approval [1] 292539 0
16/03/2015
Approval date [1] 292539 0
26/03/2015
Ethics approval number [1] 292539 0

Summary
Brief summary
This trial will compare the clinical performance of somofilcon A and formofilcon B contact lenses worn for two weeks.
The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55810 0
Mr Daniel Tilia
Address 55810 0
Clinical Research and Trials Centre (CRTC)
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country 55810 0
Australia
Phone 55810 0
+612 9385 7516
Fax 55810 0
Email 55810 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 55811 0
Mr Daniel Tilia
Address 55811 0
Clinical Research and Trials Centre (CRTC)
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country 55811 0
Australia
Phone 55811 0
+612 9385 7516
Fax 55811 0
Email 55811 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 55812 0
Mr Daniel Tilia
Address 55812 0
Clinical Research and Trials Centre (CRTC)
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country 55812 0
Australia
Phone 55812 0
+612 9385 7516
Fax 55812 0
Email 55812 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