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Trial registered on ANZCTR


Registration number
ACTRN12608000626369
Ethics application status
Approved
Date submitted
1/07/2008
Date registered
12/12/2008
Date last updated
23/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Antibiotic drop instillation during continuous contact lens wear.
Scientific title
A pilot, prospective, open label, randomised, controlled, parallel design, three-month clinical trial to assess the safety of twice daily instillation of antibiotic versus saline drops during bilateral continuous wear of marketed contact lenses in experienced wearers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 3349 0
Condition category
Condition code
Eye 3504 3504 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice daily instillation of TOBREX (tobramycin 0.3%) antibiotics drops (two drops on waking and two drops prior to sleep each night) during continuous lens wear compared to a control group using saline drops over a three month period
Intervention code [1] 3078 0
Prevention
Comparator / control treatment
Participants in the control group will instil saline drops (two drops on waking and two drops prior to sleep each night) instead of antibiotic during continuous (or extended) lens wear over a 3 month period
Control group
Active

Outcomes
Primary outcome [1] 5094 0
To investigate the safety of twice daily antibiotic drop instillation during day and night continuous wear. Primary safety variables include ocular discomfort, history, ocular examination, bulbar and limbal ocular redness, palperbral conjunctival redness and roughness, corneal and conjunctival staining. History (including medical and general health) will be recorded on the Participant History File at all visits. Ocular examination using slit-lamp biomicroscopy will be carried out at baseline and every visit.
Timepoint [1] 5094 0
Ocular examination using slit-lamp biomicroscope will be carried out at baseline and all follow-up visits (i.e. 2 weeks after baseline and monthly thereafter). Trial duration is three (3) months.
Secondary outcome [1] 7434 0
No emergence of bacterial resistance or over-growth of fungus on ocular surface. To be assessed by ocular and throat swabs and aseptic collection of worn lenses. Emergence of bacterial resistance will be examined by assessing the numbers of bacteria that show resistance to the antibiotic over time using standard "minimum inhibitory concentration" assays. Emergence of fungal overgrowth will be examined by assessing the percentage of microbial colonies that are fungi of the total microbial counts.
Timepoint [1] 7434 0
Ocular and throat swabs will be taken at baseline, 2-weeks after baseline, 4 weeks after baseline and monthly thereafter until the 3 month time point. Worn lenses will be aseptically collected at monthly visits.

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 Snellen Visual Acuity of 6/12 (metres) or better in each eye with contact lenses, which means the participant can read within 3 lines of the nominal performance for human distance visiion (i.e. 6/6).
Be experienced at wearing contact lenses
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing ocular irritation that would preclude contact lens fitting;
Had eye surgery or any systemic or ocular medication within 12 weeks immediately prior to enrolment for this trial;
Undergone corneal refractive surgery;
Worn RGP’s or orthokeratology lenses within the previous two weeks;
Contraindications to hydrogel contact lens wear;
Contraindication / allergy to tobramycin;
Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous two weeks.
Females are excluded from the 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 pre-screened for suitability by way of a routine eye examination which includes refraction, visual acuity and general eye health.
Informed consent will be obtained prior to any clinical trial procedures. Participants will be randomly allocated into either the saline or antibiotic drop instillation group. Concealed allocation will be by way of central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant will be randomly assigned to either the saline or antibiotic drop group. A randomisation plan will be generated from http://www.randomization.com/. The randomisation list will be generated based on an independent group design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Bilateral lens wear
Phase
Phase 2
Type of endpoint(s)
Safety
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] 3546 0
Commercial sector/Industry
Name [1] 3546 0
CIBA VISION Corporation
Address [1] 3546 0
11460 Johns Creek Parkway, Duluth, Georgia 30097-1556
Country [1] 3546 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CIBA VISION Corporation
Address
11460 Johns Creek Parkway, Duluth, Georgia 30097-1556
Country
United States of America
Secondary sponsor category [1] 3184 0
None
Name [1] 3184 0
Address [1] 3184 0
Country [1] 3184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5584 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 5584 0
Level 4, Rupert Myers Building
Gate 14, Barker St
University of New South Wales, NSW 2052
Ethics committee country [1] 5584 0
Australia
Date submitted for ethics approval [1] 5584 0
29/10/2008
Approval date [1] 5584 0
Ethics approval number [1] 5584 0
08/02

Summary
Brief summary
The objective of this pilot trial is to assess the safety of antibiotic drop instillation compared to a control group using saline drops instead of antibiotic during continuous lens wear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28492 0
Address 28492 0
Country 28492 0
Phone 28492 0
Fax 28492 0
Email 28492 0
Contact person for public queries
Name 11649 0
J. Ozkan
Address 11649 0
Level 5, Rupert Myers Building, Gate 14 Barker St, University of New South Wales, Kensington, NSW, 2052
Country 11649 0
Australia
Phone 11649 0
+61 2 93857516
Fax 11649 0
+61 2 93857401
Email 11649 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 2577 0
M. Willcox
Address 2577 0
Level 4, Rupert Myers Building, Gate 14 Barker St, University of New South Wales, Kensington, NSW, 2052
Country 2577 0
Australia
Phone 2577 0
+61 2 93857516
Fax 2577 0
+61 2 93857401
Email 2577 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