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Trial registered on ANZCTR


Registration number
ACTRN12609000220268
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
1/05/2009
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Daily morning replacement of contact lenses during extended wear by inexperienced contact lens wearers as a means of reducing contact lens related adverse events.
Scientific title
Evaluation of the effectiveness of daily morning contact lens replacement during extended wear as a means of reducing contact lens related ocular adverse events.
Secondary ID [1] 259838 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 4570 0
Condition category
Condition code
Eye 4863 4863 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine if daily (morning) replacement of contact lenses during extended wear reduces contact lens related adverse events compared to adverse event rates in historical control trials. Worn lenses are to be removed and discarded within 1 hour of waking each day and new lenses inserted immediately afterwards, for the duration of the study (i.e. 1 month).
Intervention code [1] 4333 0
Prevention
Comparator / control treatment
Historical control trials. Participants wore lenses on a 30 night, 31 day continuous wear schedule. At the end of this schedule lenses were disposed (i.e. monthly disposal) and new lenses inserted. The duration of the study was 6 months. Only the ocular adverse events that arose in the first 1 month of the study will be used for comparative purposes.
Control group
Historical

Outcomes
Primary outcome [1] 5717 0
To determine if daily (morning) replacement of contact lenses during extended wear reduces contact lens related adverse events compared to adverse event rates in historical control trials. Examples of contact lens (CL) related ocular adverse events (AE) include infections (microbial keratitis [MK]), inflammation of the cornea (contact lens induced peripheral and non-infectious corneal ulcer [CLPU]), contact lens induced acute red eye (CLARE), infiltrative keratitis (IK), inflammation of the conjunctiva (contact lens induced papillary conjunctivitis [CLPC]), corneal erosion, superior epithelial arcuate lesion (SEAL). Adverse events will be assessed with a slit-lamp biomicroscope (including corneal and conjunctival staining with fluorescein).
Timepoint [1] 5717 0
The duration of the study will be 1 month. Participants may be assessed for adverse events at both scheduled and unscheduled visits. Scheduled visits refer to the following visits - Baseline [BL], 1 week of daily wear [DW] (i.e. 1 week after BL), 1 week of extended wear [EW] (i.e. 2 weeks after BL) and 1 month of EW (i.e. 5 weeks afte BL). Unscheduled visits refer to all other visits during the study (e.g unexpected or follow-up visits for adverse events). EW means lenses are worn during waking and sleeping hours. DW means lenses are worn during waking hours only.
Secondary outcome [1] 241635 0
N/A
Timepoint [1] 241635 0
N/A

Eligibility
Key inclusion criteria
Be 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;
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 correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
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
Pre-existing ocular irritation that would preclude contact lens fitting;
Had eye surgery within 12 weeks immediately prior to enrollment for this trial;
Undergone corneal refractive surgery;
Contraindications to soft contact lens wear;
Be currently enrolled in another clinical tria; or have participated in a clinical trial within the previous two weeks;
Pregnant or lactating women not able to complete the study (Investigator discretion)

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)
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
Bilateral lens wear, lenses to be discarded daily
Phase
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] 1720 0
India
State/province [1] 1720 0
Hyderabad, Andhra Pradesh

Funding & Sponsors
Funding source category [1] 4758 0
Charities/Societies/Foundations
Name [1] 4758 0
Institute for Eye Research
Address [1] 4758 0
Ruper Myers Building, Gate 14 Barker St, The University of New South Wales (UNSW), Kensington, NSW, 2052
Country [1] 4758 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Ruper Myers Building, Gate 14 Barker St, The University of New South Wales (UNSW), Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 4296 0
None
Name [1] 4296 0
N/A
Address [1] 4296 0
N/A
Country [1] 4296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6801 0
Ethics committee address [1] 6801 0
Ethics committee country [1] 6801 0
Date submitted for ethics approval [1] 6801 0
13/04/2009
Approval date [1] 6801 0
Ethics approval number [1] 6801 0
Ethics committee name [2] 6813 0
L.V. Prasad Eye Institute Ethics Committee
Ethics committee address [2] 6813 0
Hyderabad Eye Research Foundation, L.V. Prasad Marg, Banjara Hills, Hyderabad, 500 034
Ethics committee country [2] 6813 0
India
Date submitted for ethics approval [2] 6813 0
13/04/2009
Approval date [2] 6813 0
Ethics approval number [2] 6813 0

Summary
Brief summary
The objective of the trial is to reduce the incidence of microbial keratitis and other ocular adverse responses related to extended contact lens wear. The hypothesis is that regular lens replacement 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 29469 0
Address 29469 0
Country 29469 0
Phone 29469 0
Fax 29469 0
Email 29469 0
Contact person for public queries
Name 12716 0
Jerome Ozkan
Address 12716 0
Level 5, Ruper Myers Building, Gate 14 Barker St, The University of New South Wales (UNSW), Kensington, NSW, 2052
Country 12716 0
Australia
Phone 12716 0
+61 2 9385 7516
Fax 12716 0
+61 2 9385 7401
Email 12716 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3644 0
Mark Willcox
Address 3644 0
Level 4, Ruper Myers Building, Gate 14 Barker St, The University of New South Wales (UNSW), Kensington, NSW, 2052
Country 3644 0
Australia
Phone 3644 0
+61 2 9385 7516
Fax 3644 0
+61 2 9385 7401
Email 3644 0
m.willcox@ier.org.au

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