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Trial registered on ANZCTR


Registration number
ACTRN12610001086055
Ethics application status
Approved
Date submitted
8/12/2010
Date registered
10/12/2010
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Stenotrophomonas maltophilia case contamination and corneal infiltrative event rates in both experienced and new contact lens wearers.
Scientific title
Prospective, open-label, daily wear study of NIGHT & DAY[Registered trade mark] contact lenses in conjunction with OPTI-FREE[Registered trade mark] RepleniSH[Registered trade mark] lens care product to evaluate Stenotrophomonas maltophilia case contamination and corneal infiltrative event rates in both experienced and new contact lens wearers.
Secondary ID [1] 253261 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 258792 0
Condition category
Condition code
Eye 258935 258935 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single group, daily wear (DW) study where 90 participants will wear NIGHT & DAY [Registered trade mark] lenses bilaterally on a daily wear (DW) basis in conjunction with OPT-FREE [Trade mark] RepleniSH [Trade mark] solution for 4 months. There will be a minimum of 5 scheduled visits: baseline, 1 month visit, 2 month visit, 3 month visit and 4 month visit. These visits will involve assessment of visual acuity and examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye). Lenses will be worn a minimum of 5 days per week, and 6 hours on the day lenses are worn.
Intervention code [1] 257726 0
Treatment: Devices
Comparator / control treatment
Correlation between contamination of contact lens cases with Stenotrophomonas maltophilia and corneal infiltrative events (CIEs)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259796 0
To determine whether a correlation exists between contamination of contact lens cases with Stenotrophomonas maltophilia and CIEs, when contact lenses and worn on a daily wear basis.
Timepoint [1] 259796 0
1, 2, 3 and 4 months
Secondary outcome [1] 268594 0
Nil
Timepoint [1] 268594 0
Nil

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 experienced or inexperienced at wearing 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 and/or during the study;
-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 study;
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 study 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 study 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 study requirements, or if 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)
Particicpant needs to satisfy inclusion/exclusion criteria. All participants are allocated the same treatment
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
Single group
Other design features
Phase
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)

Funding & Sponsors
Funding source category [1] 258185 0
Charities/Societies/Foundations
Name [1] 258185 0
Brien Holden Vision Institute
Address [1] 258185 0
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country [1] 258185 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Abbott Medical Optics, Inc
Address
1700 East St. Andrew Place
PO Box 25162
Santa Ana, CA 92799-5162, USA
Country
United States of America
Secondary sponsor category [1] 257361 0
None
Name [1] 257361 0
Address [1] 257361 0
Country [1] 257361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260178 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 260178 0
Level 4, North Wing, Rupert Myers Building (RMB), Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Ethics committee country [1] 260178 0
Australia
Date submitted for ethics approval [1] 260178 0
10/12/2010
Approval date [1] 260178 0
28/01/2011
Ethics approval number [1] 260178 0

Summary
Brief summary
This study will examine whether a correlation exists between contamination of contact lens cases with Stenotrophomonas maltophilia and CIEs, when contact lenses and worn on a daily wear basis. The hypothesis is case contamination with Stenotrophomonas maltophilia does not correlate with CIEs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32001 0
Mr Daniel Tilia
Address 32001 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 32001 0
Australia
Phone 32001 0
+61293857516
Fax 32001 0
Email 32001 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 15248 0
Mr Daniel Tilia
Address 15248 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 15248 0
Australia
Phone 15248 0
+612 9385 6165
Fax 15248 0
Email 15248 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 6176 0
Mr Daniel Tilia
Address 6176 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 6176 0
Australia
Phone 6176 0
+612 9385 6165
Fax 6176 0
Email 6176 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