Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000568213
Ethics application status
Approved
Date submitted
5/02/2009
Date registered
10/07/2009
Date last updated
12/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effects of two weeks wear of silicone hydrogel lenses used with one of two lens disinfection solutions on the surface of the eye.
Scientific title
Prospective, randomised, investigator-masked parallel treatment study in up to 50 participants of the effects of two weeks daily wear of silicone hydrogel lenses used in conjunction with polyhexamethylene biguanide (PHMB) or peroxide-based contact lens solutions on the ocular surface health.
Secondary ID [1] 283575 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Wear 4273 0
Condition category
Condition code
Eye 4501 4501 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To investigate ocular surface changes after contact lens wear used in combination with various types of contact lens solutions and to correlate with subjective symptoms. Participants will wear silicone hydrogel lenses on a daily wear basis for a minimum of two weeks. Participants will use either a polyhexamethylene biguanide (PHMB) or a peroxide-based contact lens solution (randomly assigned) for cleaning and storing their lenses overnight. Participants will be instructed to discontinue lens wear or use the peroxide-based solution for an additional week and recovery after this additional wash-out period measured.
Intervention code [1] 4001 0
Treatment: Devices
Comparator / control treatment
Parallel control group: the pexoxide-based solution group will be the comparator.
Control group
Active

Outcomes
Primary outcome [1] 5383 0
To assess ocular surface changes after contact lens wear. Measurements will include tear secretion rate using Phenol red thread test, tear osmolarity using a vapor pressure osmometer, tear fluorescein break-up time, ocular surface staining and number of goblet cells using impression cytology for the conjunctival surface.
Timepoint [1] 5383 0
Baseline, 1 day, 1 week, 2 week and after 1 week recovery
Secondary outcome [1] 9051 0
To correlate ocular surface changes with subjective symptoms. Standardised questionnaires (McMonnies questionnaire, ocular symptoms questionnaires) will be used to assess subjective symptoms.
Timepoint [1] 9051 0
Baseline, 1 day, 1 week, 2 week and after 1 week recovery

Eligibility
Key inclusion criteria
Suitability to contact lens wear and ability to be corrected with the range of contact lens powers and base curves available from the manufacturer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications to contact lens wear.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. Study numbers will be issued consecutively to subjects as they give informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2009
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
17/04/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4456 0
University
Name [1] 4456 0
University of New South Wales Science Faculty Early Career Researcher Grant
Country [1] 4456 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales
School of Optometry and Vision Science
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 4015 0
None
Name [1] 4015 0
Address [1] 4015 0
Country [1] 4015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6512 0
University of New South Wales' Human Research Ethics Advisory (HREA) Biomedical Panel
Ethics committee address [1] 6512 0
School of Optometry and Vision Science
The University of New South Wales
North Wing, Rupert Myers Building
Gate 14 Barker Street
Kensington NSW 2033
Ethics committee country [1] 6512 0
Australia
Date submitted for ethics approval [1] 6512 0
01/12/2008
Approval date [1] 6512 0
15/12/2008
Ethics approval number [1] 6512 0
084089

Summary
Brief summary
Symptoms akin to those experienced by dry eye sufferers are often experienced by contact lens wearers. Some of the preservatives used in contact lens cleaning solutions are known to cause mild damage to the eye's surface. This study aims to investigate the changes to the eye's surface associated with various types of contact lens solutions and whether this is related to any symptoms of dryness.
Trial website
Trial related presentations / publications
1. Jalbert I, Wong D, Madigan M. The short term effects of soft contact lenses worn in combination with two types of contact lens storage solutions on ocular surface health markers. Proc Int Society for Contact Lens Research, Hersonissos, Crete, Greece, 2009.
Public notes

Contacts
Principal investigator
Name 29253 0
Dr Isabelle Jalbert
Address 29253 0
School of Optometry and Vision Science
University of New South Wales
Sydney NSW 2052
Country 29253 0
Australia
Phone 29253 0
+61-2-9385-9816
Fax 29253 0
Email 29253 0
[email protected]
Contact person for public queries
Name 12500 0
Dr Dr Isabelle Jalbert
Address 12500 0
School of Optometry and Vision Science
The University of New South Wales
North Wing, Rupert Myers Building
Gate 14 Barker Street
Kensington NSW 2033
Country 12500 0
Australia
Phone 12500 0
+61-2-9385-9816
Fax 12500 0
+61-2-9313-6243
Email 12500 0
[email protected]
Contact person for scientific queries
Name 3428 0
Dr Dr Isabelle Jalbert
Address 3428 0
School of Optometry and Vision Science
The University of New South Wales
North Wing, Rupert Myers Building
Gate 14 Barker Street
Kensington NSW 2033
Country 3428 0
Australia
Phone 3428 0
+61-2-9385-9816
Fax 3428 0
+61-2-9313-6243
Email 3428 0
[email protected]

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.