Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000939998
Ethics application status
Approved
Date submitted
31/08/2011
Date registered
1/09/2011
Date last updated
14/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Benchmarking evaluation of OPTI-FREE [Registered trade mark] EverMoist [Registered trade mark] multi-purpose disinfecting solution when used with two silicone hydrogel contact lenses
Scientific title
A prospective, bilateral, open-label, parallel group , randomised clinical trial to evaluate OPTI-FREE [Registered trade mark] EverMoist for ocular surface effects, subjective response and lens case contamination when used in conjunction with two silicone hydrogel contact lenses in both experienced and new wearers
Secondary ID [1] 262969 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular surface effects 270693 0
Ocular comfort 270696 0
Contact lens case contamination 270697 0
Condition category
Condition code
Eye 270868 270868 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, bilateral, open-label, parallel group, daily wear (DW) study where 80 participants will be randomised to bilaterally wear either senofilcon A or lotrafilcon A contact lenses on a daily wear basis in conjunction with OPTI-FREE [Registered trade mark] EverMoist [Registered trade mark] multipurpose disinfecting solution (MPDS) for 3 months. There will be 5 scheduled visits: baseline, 2 hour visit, 2 week visit, 1 month visit and 3 month visit. These visits will involve assessment of visual acuity, ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye) and assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale. Lenses will be worn a minimum of 5 days per week, 6 hours per day. EverMoist will be used after lens removal and as per manufacturer’s recommendation: Rub lenses with EverMoist (20 seconds), rinse lenses with EverMoist (10 seconds) and store in EverMoist for at least 6 hours. Solution is not to be re-used.
Intervention code [1] 269310 0
Treatment: Devices
Comparator / control treatment
Comparisons will be made between the 2 lens types and also with the following published data:
Carnt, N., V. Evans, et al. (2008). "IER Matrix Update: Adding Another Silicone Hydrogel." Contact Lens Spectrum: http://www.clspectrum.com/article.aspx?article=101452.
Carnt, N. A., V. E. Evans, et al. (2009). "Contact lens-related adverse events and the silicone hydrogel lenses and daily wear care system used." Arch Ophthalmol. 127(12): 1616-1623.
Willcox, M. D., N. Carnt, et al. (2010). "Contact lens case contamination during daily wear of silicone hydrogels." Optom Vis Sci. 87(7): 456-464.

Data is published from clinical trials conducted at the Brien Holden Institute (formerly the Institute for Eye Research) between 2004-2008
Control group
Active

Outcomes
Primary outcome [1] 279548 0
Ocular surface effetcs as assessed with a slit lamp biomicroscope, which is a specialised microscope to view the eye
Timepoint [1] 279548 0
2 hours after baseline and after 2 weeks, 1 month and 3 months of daily wear
Secondary outcome [1] 287880 0
Ocular comfort as measured with 1-10 numeric rating scales
Timepoint [1] 287880 0
Immediately after lens insertion, 2 hours after insertion and after 2 weeks, 1 month and 3 months of daily wear
Secondary outcome [2] 287881 0
Contamination rate of contact lens cases as measured by contamination rate and cultured species
Timepoint [2] 287881 0
Cases will be collected after one month's use at the 1 month and 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 6/12 (20/40) or better in each eye with contact lenses.
Be experienced or inexperienced at wearing contact lenses.
Be able to insert and remove contact lenses.
Be willing to not wear contact lenses for at least 48 hours before the commencement of the clinical trial (after informed consent).
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, 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.
N.B.: 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 first 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* (either at enrolment or during the course of the trial).
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)
Participants who satisfy the inclusion/exclusion criteria are enrolled in the trial and are given a sequential participant number. A computer generated randomisation plan is used to allocate contact lens type to each participant, based on their unique participant number
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
29/09/2011
Actual
10/11/2011
Date of last participant enrolment
Anticipated
Actual
22/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269776 0
Charities/Societies/Foundations
Name [1] 269776 0
Brien Holden Vision Institute
Country [1] 269776 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Optics, Inc
Address
1700 East St. Andrew Place

PO Box 25162 Santa Ana, CA 92799-5162
Country
United States of America
Secondary sponsor category [1] 268816 0
None
Name [1] 268816 0
Address [1] 268816 0
Country [1] 268816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271733 0
Bellberry Limited
Ethics committee address [1] 271733 0
Ethics committee country [1] 271733 0
Australia
Date submitted for ethics approval [1] 271733 0
15/09/2011
Approval date [1] 271733 0
07/10/2011
Ethics approval number [1] 271733 0
2011-09-434

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

Contacts
Principal investigator
Name 33101 0
Mr Daniel Tilia
Address 33101 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 33101 0
Australia
Phone 33101 0
+612 9385 7516
Fax 33101 0
Email 33101 0
[email protected]
Contact person for public queries
Name 16348 0
Daniel Tilia
Address 16348 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 16348 0
Australia
Phone 16348 0
+612 9385 7516
Fax 16348 0
Email 16348 0
[email protected]
Contact person for scientific queries
Name 7276 0
Daniel Tilia
Address 7276 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 7276 0
Australia
Phone 7276 0
+612 9385 7516
Fax 7276 0
Email 7276 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.