Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000920099
Ethics application status
Approved
Date submitted
6/10/2010
Date registered
29/10/2010
Date last updated
9/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Antibiotic drop efficacy trial
Scientific title
A proof-of-principle, prospective, open label, randomised, controlled, parallel design, one-month clinical trial to determine if prophylactic instillation of antibiotic drops during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related ocular inflammatory adverse events.
Secondary ID [1] 252979 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 258340 0
Condition category
Condition code
Eye 258525 258525 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test group will be randomised to instil Moxifloxacin antibiotic drops twice a day into each eye on waking and prior to sleep (in the evening). Commercially available siliconhydrogel lenses are to be worn on a continuous wear basis (that is, during the day and night) for approximately I month
Intervention code [1] 257354 0
Prevention
Comparator / control treatment
Control group will instil unit dose saline (5mL, 0.9% sodium chloride)lubricant as treatment twice a day into each eye on waking and prior to sleep (in the evening). Lenses are to be worn on a continuous wear basis (that is, during the day and night) for approximately I month
Control group
Active

Outcomes
Primary outcome [1] 259366 0
Reduction of contact lens related inflammatory ocular adverse events compared to control group. Ocular redness (bulbar limbal and palpebral), palpebral roughness and corneal and conjunctival staining will be assessed and recorded using the Brien Holden Vision Institute Grading scales. History (including medical and general health) at baseline, and changes from baseline history that occur between visits, will be recorded in the source documentation at each visit.
Timepoint [1] 259366 0
Ocular examination using slit-lamp biomicroscopy will be carried out at baseline and all follow up visits (i.e. 1 night, 1 week (if a neophyte- new contact lens wearer) and 1 Month)
Secondary outcome [1] 265871 0
Nil
Timepoint [1] 265871 0
Nil

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 male and 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 / spectacles,
Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses / spectacles,
Be experienced or may be inexperienced at wearing contact lenses
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition that would preclude contact lens fitting,
Had eye surgery within 12 weeks immediately prior to enrolment for this trial,
Undergone previous corneal refractive surgery,
Contraindications to contact lens wear,
Allergy or intolerance to moxifloxacin or other quinolones/fluoroquinolones,
Be currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks for longer-term studies and 48 hours between short-term studies,
Female are excluded from this 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 lubricant 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)
Participants will be randomly assigned to either the saline or antibiotic drop grou. 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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 2955 0
India
State/province [1] 2955 0
hyderabad

Funding & Sponsors
Funding source category [1] 257806 0
Charities/Societies/Foundations
Name [1] 257806 0
Brien Holden Vision Institute
Country [1] 257806 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street,
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 257011 0
None
Name [1] 257011 0
Address [1] 257011 0
Country [1] 257011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259829 0
Ethics Committee LV Prasad eye institute
Ethics committee address [1] 259829 0
LV Prasad Eye Institute
LV Prasad Marg, Road No.2, Banjara Hills
Hyderabad, 500 034
India
Ethics committee country [1] 259829 0
India
Date submitted for ethics approval [1] 259829 0
Approval date [1] 259829 0
30/08/2010
Ethics approval number [1] 259829 0
LEC 08213

Summary
Brief summary
The objective of this proff of principle trial is to determine if prophylactic antibiotic drop used during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related inflammatory ocular adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31744 0
Address 31744 0
Country 31744 0
Phone 31744 0
Fax 31744 0
Email 31744 0
Contact person for public queries
Name 14991 0
J. Ozkan
Address 14991 0
Brien Holden Vision Institute
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street,
UNSW Sydney NSW 2052
Australia
Country 14991 0
Australia
Phone 14991 0
+61 2 93857516
Fax 14991 0
+61 2 9385 7401
Email 14991 0
[email protected]
Contact person for scientific queries
Name 5919 0
M.Willcox
Address 5919 0
Level 4, North Wing, Rupert Myers Building
Gate 14, Barker Street,
UNSW Sydney NSW 2052
Australia
Country 5919 0
Australia
Phone 5919 0
+61 2 93857516
Fax 5919 0
+61 2 9385 7401
Email 5919 0
m.willcoxbrienholdenvisioninstitute.org

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
No additional documents have been identified.