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Trial registered on ANZCTR


Registration number
ACTRN12612001098820
Ethics application status
Approved
Date submitted
11/10/2012
Date registered
16/10/2012
Date last updated
25/03/2014
Type of registration
Retrospectively 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
Prospective, controlled, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers
Secondary ID [1] 281375 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
R&R Efficacy study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study purpose is to investigate the efficacy of daily morning cleaning of lenses with a multipurpose disinfection solution as a means of reducing contact lens related ocular adverse events. 287601 0
Condition category
Condition code
Eye 287934 287934 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, controlled, 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). For the test group, each morning following waking, the lenses will be removed, several drops of Biotrue multipurpose solution applied to the lens. The lenses are then cleaned by rubbing and then rinsing with the same solution and then reinserted on eye.
Intervention code [1] 285843 0
Treatment: Devices
Intervention code [2] 285844 0
Prevention
Comparator / control treatment
The control group will wear the same lens type for the same duration but will not remove the lenses daily for cleaning (i.e. standard extended wear)
Control group
Active

Outcomes
Primary outcome [1] 288143 0
To determine if daily cleaning of contact lenses during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related ocular adverse events, including infiltrative keratitis, contact lens induced peripheral ulcer and acute red eye. Assessment will be conducted using a slit lamp biomicroscope.
Timepoint [1] 288143 0
Baseline, 1 week, 1 month, 3 months
Secondary outcome [1] 299497 0
To determine if daily cleaning of contact lenses during continuous wear of silicone hydrogel contact lenses reduces the contamination rate of contact lenses. Worn lenses will be removed aseptically by the clinician at monthly scheduled visits, placed in phosphate buffered saline and sent for microbiological analysis.
Timepoint [1] 299497 0
Baseline, 1 month, 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.
-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/spectacles.
-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 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, Sjögrens 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 any therapeutic ocular medication up to 4 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.
-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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated into either the test group (lenses to be cleaned each morning) or control group (standard continuous wear, i.e. no daily cleaning required). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated generated from http://www.randomization.com/. A randomisation list will be generated by the biostatistician and based on an independent group design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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] 4593 0
India
State/province [1] 4593 0
Hyderabad

Funding & Sponsors
Funding source category [1] 286129 0
Charities/Societies/Foundations
Name [1] 286129 0
Brien Holden Vision Institute
Address [1] 286129 0
Level 5, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country [1] 286129 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 284941 0
None
Name [1] 284941 0
Address [1] 284941 0
Country [1] 284941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288177 0
Hyderabad Eye Research Foundation Ethics Committee
Ethics committee address [1] 288177 0
L V Prasad Eye Institute, L V Prasad Marg, Banjara Hills, Hyderabad, 500-034
Ethics committee country [1] 288177 0
India
Date submitted for ethics approval [1] 288177 0
Approval date [1] 288177 0
31/07/2012
Ethics approval number [1] 288177 0
LEC 11-192

Summary
Brief summary
The hypothesis for this study is that regular lens cleaning with a contact lens disinfection solution during extended wear exposes the eye to a clean lens surface thereby reducing bacterial build-up on the lens surface, compared to standard extended wear, resulting in less bacterially driven ocular adverse events.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 34815 0
Dr Varsha Rathi
Address 34815 0
L V Prasad Eye Institute, Banjara Hills, Hyderabad, 500-034
Country 34815 0
India
Phone 34815 0
+91 40 3061 2345
Fax 34815 0
+91 40 2345 8271
Email 34815 0
communications@lvpei.org
Contact person for public queries
Name 18062 0
Mr Jerome Ozkan
Address 18062 0
Level 5, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country 18062 0
Australia
Phone 18062 0
61293857516
Fax 18062 0
Nil
Email 18062 0
j.ozkan@brienholdenvision.org
Contact person for scientific queries
Name 8990 0
Mr Jerome Ozkan
Address 8990 0
Level 5, Rupert Myers Building, Barker St, University of New South Wales, Sydney, NSW, 2052
Country 8990 0
Australia
Phone 8990 0
61293857516
Fax 8990 0
Nil
Email 8990 0
j.ozkan@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