Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000521628
Ethics application status
Approved
Date submitted
12/05/2014
Date registered
15/05/2014
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of several contact lenses in experienced and non-experienced wearer to determine differences in lens comfort and lens clinical performance when lenses are worn for one month
Scientific title
A prospective, unmasked, parallel clinical trial assessing silicone hydrogel and hydrogel contact lenses for clinical performance when used on a daily wear basis for one month
Secondary ID [1] 284507 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 291766 0
Ocular surface response to contact lenses 291767 0
Condition category
Condition code
Eye 292125 292125 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, parallel, unmasked clinical trial. Participants will wear at least one lens for 30 days using a specified lens care solution if required. A minimum of 40 participants will be included in the evaluation of each lens type and up to 400 participants may be enrolled in the trial. All lenses will be worn bilaterally, on a daily wear basis for 30 days (1 month). 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. Lenses which may be assessed include re-usable, monthly replacement silicone hydrogel lenses (filcon 1, somofilcon A, comfilcon A), single-use, daily disposable silicone hydrogel lenses (filcon 1, formofilcon B, stenfilcon A, somofilcon A). and single-use, daily disposable hydrogel lenses (etafilcon A, omofilcon A). Solutions which may be used include Biotrue (Trademark), renu (Registered Trademark) fresh (Trademark), OPTI-FREE (Registered Trademark) Puremoist (Registered Trademark), AOSEPT (Registered Trademark) Plus, Revitalens OcuTec (Registered Trademark) and Complete (Registered Trademark) Easy Rub. Each assessment will have 3 visits: Baseline/dispensing, 2 weeks and 1 month. 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). Lenses will be worn a minimum of 5 days per week, 6 hours per day. Solutions will be used on re-usable lenses after lens removal using a rub/rinse cleaning regime- rub lenses with solution (5 seconds), rinse lenses with solution (5seconds) and store in solution for at least 6 hours. Solution is not to be reused. Lenses will be replaced as per manufacturer’s recommendation (either after 1 month or after single use as specified above). Participants can wear up to 4 different contact lens type. A 2 week wash-out where habitual correction is worn is required when testing more than one lens type.
Intervention code [1] 289265 0
Treatment: Devices
Comparator / control treatment
Formofilcon B lenses will serve as control for the silicone hydrogel group and etafilcon A lenses will serve as control for the hydrogel group
Control group
Active

Outcomes
Primary outcome [1] 292004 0
To compare subjective response between formofilcon B and etafilcon A contact lenses and other commercial silicone hydrogel and hydrogel contact lenses. This will assessed using 1-10 numeric rating scales and Likert scales assessing frequency of symptoms
Timepoint [1] 292004 0
baseline/dispensing, 2 weeks, 1 month
Secondary outcome [1] 307985 0
To compare physiological response between formofilcon B and etafilcon A contact lenses and other commercial silicone hydrogel and hydrogel contact lenses. This will be assessed by examination with a slit-lamp biomicroscope
Timepoint [1] 307985 0
baseline/dispensing, 2 weeks, 1 month

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 6/12 (20/40) or better in each eye with contact lenses.
May be an experienced or inexperienced lens wearer.
Be able to insert and remove contact lenses.
Be willing to undergo a 2 week wash-out with habitual correction between lens assessments.
Minimum age
18 Years
Maximum age
No limit
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, Sjorens 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
Non-randomised 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 assessed will be determined by the Sponsor. Participants will be enrolled to assess a lens type until at least 40 are recruited. Participants can assess more than one lens type provided only one lens type is assessed at any time, to a maximum of 4 different lens types.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
19/05/2014
Actual
16/05/2014
Date of last participant enrolment
Anticipated
Actual
4/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289152 0
Charities/Societies/Foundations
Name [1] 289152 0
Brien Holden Vision Institute
Country [1] 289152 0
Australia
Primary sponsor type
Charities/Societies/Foundations
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] 287817 0
None
Name [1] 287817 0
Address [1] 287817 0
Country [1] 287817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290924 0
Bellberry Limited
Ethics committee address [1] 290924 0
Ethics committee country [1] 290924 0
Australia
Date submitted for ethics approval [1] 290924 0
02/04/2014
Approval date [1] 290924 0
30/04/2014
Ethics approval number [1] 290924 0
2014-04-160

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

Contacts
Principal investigator
Name 48002 0
Mr Daniel Tilia
Address 48002 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 48002 0
Australia
Phone 48002 0
+612 9385 7516
Fax 48002 0
Email 48002 0
[email protected]
Contact person for public queries
Name 48003 0
Daniel Tilia
Address 48003 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 48003 0
Australia
Phone 48003 0
+612 9385 7516
Fax 48003 0
Email 48003 0
[email protected]
Contact person for scientific queries
Name 48004 0
Daniel Tilia
Address 48004 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 48004 0
Australia
Phone 48004 0
+612 9385 7516
Fax 48004 0
Email 48004 0
[email protected]

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.