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Trial registered on ANZCTR


Registration number
ACTRN12610000336088
Ethics application status
Approved
Date submitted
19/03/2010
Date registered
28/04/2010
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of daily cleaning of contact lenses on adverse event rates in new and experienced lens wearers
Scientific title
A prospective, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during three months extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers
Secondary ID [1] 251645 0
NIL
Universal Trial Number (UTN)
Trial acronym
R&R study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The purpose of this study is to investigate the efficacy of regular morning cleaning of lenses with a multipurpose disinfection solution as a means of reducing microbial keratitis and other contact lens related ocular inflammatory adverse events. 256957 0
Condition category
Condition code
Eye 257100 257100 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during three months extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers. Lenses will be worn for one month extended wear (i.e. during the day and night). Each morning, following waking, the lenses will be removed, several drops of COMPLETE multipurpose solution easy-rub formula (PHMB/polyhexamethylene biguanide 0.0001%; Abbott Medical Optics, USA) applied to the lens. The lenses are then cleaned by rubbing and then rinsing with the same solution and then reinserting on eye.
Intervention code [1] 256134 0
Treatment: Devices
Intervention code [2] 256359 0
Prevention
Comparator / control treatment
The proposed study will be compared to a historical control conducted in 2008-09 at L V Prasad Eye Institute (LVPEI), Hyderabad.
Control group
Historical

Outcomes
Primary outcome [1] 257992 0
Reduction of contact lens related ocular adverse events compared to adverse event rates in a historical control trial and previously conducted similar trials conducted at the LV Prasad Eye Institute. Examples of contact lens related ocular adverse events include infiltrative keratitis, peripheral and non-infectious corneal ulcer, acute red-eye responses and microbial keratitis. The primary tool used to assess these adverse events is the slit-lamp biomicroscopy.
Timepoint [1] 257992 0
Baseline, 1 week, 1 month, 3 months
Secondary outcome [1] 263548 0
Nil
Timepoint [1] 263548 0
Nil

Eligibility
Key inclusion criteria
-Able to read, comprehend English and give informed consent as demonstrated by signing a record of informed consent;
-Be at least 18 years old;
-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;
-Have vision that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
-Be experienced or may be 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
-Have previously experienced a severe or significant contact lens related ocular adverse event including microbial keratitis (MK), infiltrative keratitis (IK), contact lens acute red eye (CLARE) and/or contact lens peripherial ulcer (CLPU).
-Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
-An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
-Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the 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 manner or risk providing a false positive.
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
-Previous corneal refractive surgery;
-Any rigid gas permeable (RGP) or orthokeratology lens wear within the previous 2 weeks;
-Contraindications to contact lens wear;
-Currently enrolled in a clinical trial
-Participated in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
-Be pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant numbering will occur sequentially commencing with ‘001’. Replacement participants will not assume an already allocated number (i.e. of the dropout) but will be allocated the next sequential study number available.

There will be no randomisation of participants in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
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 outside Australia
Country [1] 2538 0
India
State/province [1] 2538 0
Hyderabad

Funding & Sponsors
Funding source category [1] 256637 0
Charities/Societies/Foundations
Name [1] 256637 0
Brien Holden Vision Institute
Address [1] 256637 0
Level 5, North Wing, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country [1] 256637 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, North Wing, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 256138 0
None
Name [1] 256138 0
Address [1] 256138 0
Country [1] 256138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258699 0
L V Prasad Ethics Committee
Ethics committee address [1] 258699 0
L V Prasad Marg, Banjara Hills, Hyderabad,
500-034
Ethics committee country [1] 258699 0
India
Date submitted for ethics approval [1] 258699 0
25/03/2010
Approval date [1] 258699 0
29/03/2010
Ethics approval number [1] 258699 0
LEC08155

Summary
Brief summary
The hypothesis for this study is that regular lens cleaning (using a rub and rinse technique) with a multipurpose disinfection solution during extended wear exposes the eye to a clean lens surface thereby reducing bacterial build-up on the lens surface resulting in less bacterially driven ocular adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30923 0
Address 30923 0
Country 30923 0
Phone 30923 0
Fax 30923 0
Email 30923 0
Contact person for public queries
Name 14170 0
Jerome Ozkan
Address 14170 0
Level 5, Rupert Myers Building, Gate 14, Barker St, University of New South Wales, Sydney, 2052
Country 14170 0
Australia
Phone 14170 0
61293857516
Fax 14170 0
Email 14170 0
j.ozkan@brienholdenvision.org
Contact person for scientific queries
Name 5098 0
Mark Willcox
Address 5098 0
Level 5, Rupert Myers Building, Gate 14, Barker St, University of New South Wales, Sydney, 2052
Country 5098 0
Australia
Phone 5098 0
61293857516
Fax 5098 0
Email 5098 0
m.willcox@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