Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000036314
Ethics application status
Approved
Date submitted
21/01/2008
Date registered
23/01/2008
Date last updated
23/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Daily replacement of contact lenses during extended wear.
Scientific title
Evaluation of the effectiveness of daily contact lens replacement during extended wear as a means of reducing contact lens related ocular adverse events.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
contact lens wear 2708 0
Condition category
Condition code
Eye 2832 2832 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine if daily replacement of lenses during continuous (or extended) wear reduces contact lens related ocular adverse events compareed to adverse event rates in historical control trial. Worn lenses are to be removed and discarded each day prior to sleep and new lenses inserted immediately afterwards. Participants will then sleep in their lenses.
Intervention code [1] 2446 0
Prevention
Comparator / control treatment
Historical control trial (conducted in 2005/2006). 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 for 6 months. Only the ocular adverse events that arose in the first 3 months of the historic control trial will be used for comparative purposes.
Control group
Historical

Outcomes
Primary outcome [1] 3713 0
To determine if daily replacement of lenses during continuous (or extended) wear reduces contact lens related ocular adverse events compareed to adverse event rates in historical control trial. Examples of CL-related ocular AE's include infectious (microbial keratitis [MK]), inflammation of the cornea (contact lens induced peripheral and non-infection 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] 3713 0
The duration of the study is 3 months. Participants may be assessed for adverse events at scheduled visits (1 week daily lens weart [neophytes only], 1 week extended wear (EW), 1 month EW and 3 months extended wear) and at unscheduled visits.
Secondary outcome [1] 6263 0
N/A
Timepoint [1] 6263 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 experienced or may be inexperienced at wearing contact lenses
Minimum age
18 Years
Maximum age
Not stated
Sex
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;
Worn RGP’s or orthokeratology lenses within the previous two weeks
Contraindications to soft contact lens wear;
Contraindication / allergy to in-eye solutions
Be currently enrolled in another clinical trial 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
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 733 0
India
State/province [1] 733 0
Hyderabad, Andhra Pradesh

Funding & Sponsors
Funding source category [1] 2962 0
Charities/Societies/Foundations
Name [1] 2962 0
Institute for Eye Research
Country [1] 2962 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Rupert Myers Building, Gate 14 Barker St, UNSW, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 2673 0
None
Name [1] 2673 0
Address [1] 2673 0
Country [1] 2673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4912 0
Vision CRC and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 4912 0
Level 4, Rupert Myers Building, Gate 14 Barker St, UNSW, Kensington, NSW, 2052
Ethics committee country [1] 4912 0
Australia
Date submitted for ethics approval [1] 4912 0
Approval date [1] 4912 0
19/12/2008
Ethics approval number [1] 4912 0
07/35

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 renewal of the lens surface 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 28295 0
Address 28295 0
Country 28295 0
Phone 28295 0
Fax 28295 0
Email 28295 0
Contact person for public queries
Name 11452 0
Jerome Ozkan
Address 11452 0
Level 5, Rupert Myers Building, Gate 14 Barker St, UNSW, Kensington, NSW, 2052
Country 11452 0
Australia
Phone 11452 0
0293857516
Fax 11452 0
0293857401
Email 11452 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 2380 0
Mark Willcox
Address 2380 0
Level 4, Rupert Myers Building, Gate 14 Barker St, UNSW, Kensington, NSW, 2052
Country 2380 0
Australia
Phone 2380 0
0293857516
Fax 2380 0
0293857401
Email 2380 0
m.willcox@ier.org.au

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
SourceTitleYear of PublicationDOI
EmbaseComparative Analysis of Adverse Events from a Series of Proof-of-Principle Extended Wear Studies.2019https://dx.doi.org/10.1097/ICL.0000000000000546
Dimensions AIThe Effect of Daily Lens Replacement During Overnight Wear on Ocular Adverse Events2012https://doi.org/10.1097/opx.0b013e31827731ac
N.B. These documents automatically identified may not have been verified by the study sponsor.