Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000915853
Ethics application status
Approved
Date submitted
24/08/2012
Date registered
28/08/2012
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a novel multi-purpose contact lens solution
Scientific title
A prospective, bilateral, cross-over study to evaluate the safety and subjective acceptance of a novel contact lens multipurpose disinfecting solution and compare with a commercial solution during 1 month contact lens daily wear on experienced lens wearers
Secondary ID [1] 281084 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular surface effects 287238 0
Subjective comfort 287261 0
Condition category
Condition code
Eye 287562 287562 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomised (solution allocation), bilateral, cross-over clinical trial where a minimum of 30 experienced contact lens wearers will use a commercial multipurpose solution (MPS) (OPTI-FREE (Registered Trademark) Puremoist (Registered Trademark)) (OFPM) and a novel MPS (BHVI7) in conjunction with Clariti (Trademark) and or ACUVUE (Registered Trademark) OASYS (Trademark) contact lenses on a daily wear basis for approximately two or four months. There will be 2 or 4 stages in this study, with each stage corresponding to using one of the MPS for one month. There will be 8 or 16 scheduled visits, with 4 visits per stage: baseline/dispensing visit, 2 hour post insertion, 2 weeks and 1-month visits. 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. All solutions will be used after lens removal and as per manufacturer’s recommendation: 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. Clariti contact lenses will be replaced monthly and ACUVUE OASYS 2-weekly. There will be a 48 hour wash-out where no contact lenses are worn before the commencement of each stage.
Intervention code [1] 285537 0
Treatment: Devices
Comparator / control treatment
OFPM will serve as control.
Control group
Active

Outcomes
Primary outcome [1] 287815 0
Ocular surface effetcs as assessed with a slit lamp biomicroscope, which is a specialised microscope to view the eye
Timepoint [1] 287815 0
baseline, 2 hours post lens insertion, 2 weeks, 1 month
Secondary outcome [1] 298877 0
Ocular comfort as measured with 1-10 numeric rating scales
Timepoint [1] 298877 0
baseline, 2 hours post lens insertion, 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.
Be experienced at wearing contact lenses.
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.
Correctable to at least 6/12 or better in each eye with contact lenses.
Be willing to not wear contact lenses for at least 2 days before each stage of the clinical trial.
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, 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 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 2 days between in-house studies.
Pregnancy* (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient)

Study design
Purpose of the study
Diagnosis
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 and are given a sequential participant number. A randomisation plan (see below) is used to allocate contact lens solution to each participant, based on their unique participant number. A randomisation list will be generated by the biostatistician and applied through the Clinic Data Management system.
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/.
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
Masking only occurs at the beginning of each stage
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2012
Actual
13/11/2012
Date of last participant enrolment
Anticipated
30/04/2013
Actual
27/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285870 0
Charities/Societies/Foundations
Name [1] 285870 0
Brien Holden Vision Institute
Country [1] 285870 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] 284694 0
None
Name [1] 284694 0
Address [1] 284694 0
Country [1] 284694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287898 0
Bellberry Limited
Ethics committee address [1] 287898 0
Ethics committee country [1] 287898 0
Australia
Date submitted for ethics approval [1] 287898 0
30/08/2012
Approval date [1] 287898 0
10/09/2012
Ethics approval number [1] 287898 0

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

Contacts
Principal investigator
Name 34612 0
Mr Daniel Tilia
Address 34612 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 34612 0
Australia
Phone 34612 0
+61293857516
Fax 34612 0
Email 34612 0
[email protected]
Contact person for public queries
Name 17859 0
Daniel Tilia
Address 17859 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 17859 0
Australia
Phone 17859 0
+61293857516
Fax 17859 0
Email 17859 0
[email protected]
Contact person for scientific queries
Name 8787 0
Daniel Tilia
Address 8787 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 8787 0
Australia
Phone 8787 0
+612 9385 7516
Fax 8787 0
Email 8787 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.