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Trial registered on ANZCTR


Registration number
ACTRN12609000431224
Ethics application status
Approved
Date submitted
20/05/2009
Date registered
10/06/2009
Date last updated
31/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, cross-over, randomised clinical trial to establish the ocular comfort profile with and without lens wear over a 12 hour period and to assess the changes in the profile when lens are inserted at different times of the day and worn for 4 hours, with AIR OPTIX (trademark) AQUA contact lenses
Scientific title
A prospective, cross-over, randomised clinical trial to establish the ocular comfort profile with and without lens wear over a 12 hour period and to assess the changes in the profile in experienced wearers when lens are inserted at different times of the day and worn for 4 hours, with AIR OPTIX (trademark) AQUA contact lenses
Secondary ID [1] 252703 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 4825 0
Condition category
Condition code
Eye 237166 237166 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, cross-over, randomised, open label clinical trial with participants wearing AIR OPTIX AQUA contact lenses bilaterally for four days and one day of no lens wear, making five stages in total as defined below, following initial lens dispense.
Participants will initially be fitted with contact lenses. This is followed by five stages, with each stage corresponding to a twelve hour period. The starting time for each stage will preferably be determined for each participant as being the time they would normally insert their contact lenses.
The order of stages will be randomised. Subjective responses will be evaluated using a Take Home Questionnaire (THQ) at approximately every two hours during each stage.
Intervention code [1] 4600 0
Treatment: Devices
Intervention code [2] 4601 0
Behaviour
Comparator / control treatment
Active control-crossover study
Control group
Active

Outcomes
Primary outcome [1] 237986 0
Subjective ocular comfort with contact lenses. This will be assessed by using questionnaires which are to be completed at regular time points during the day.
Timepoint [1] 237986 0
day 1, 2, 3,4,5
Secondary outcome [1] 242110 0
None
Timepoint [1] 242110 0
not applicable

Eligibility
Key inclusion criteria
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;
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;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Be able to insert and remove contact lenses;
Experienced contact lens wearer;
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the study;
Use of or a need for any systemic medication or topical medications (including systemic antihistamines) which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial;
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies;

The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.

N.B. Whilst pregnant or lactating women are not excluded from the trial, they must be able to complete the study.

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)
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
Crossover
Other design features
Phase
Not Applicable
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4985 0
Charities/Societies/Foundations
Name [1] 4985 0
Institute for Eye Research
Address [1] 4985 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country [1] 4985 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CIBA VISION
Address
11460 Johns Creek Parkway
Duluth, GA 30097-1556
Country
United States of America
Secondary sponsor category [1] 4619 0
None
Name [1] 4619 0
Address [1] 4619 0
Country [1] 4619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7088 0
The Vision Cooperative Research Centre (CRC) and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 7088 0
Level 4, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Ethics committee country [1] 7088 0
Australia
Date submitted for ethics approval [1] 7088 0
18/03/2009
Approval date [1] 7088 0
22/04/2009
Ethics approval number [1] 7088 0
0906

Summary
Brief summary
The aim of this trial is to establish the ocular comfort profile with and without lens wear over a 12 hour period. The trial also aims to assess how the profiles are influenced by lens insertion at different times of the day and worn for four hours.

The hypothesis for this trial is ocular comfort will decrease during the day and ocular comfort with lens wear will be rated worse than with no lens wear
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29625 0
Address 29625 0
Country 29625 0
Phone 29625 0
Fax 29625 0
Email 29625 0
Contact person for public queries
Name 12872 0
Daniel Tilia
Address 12872 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 12872 0
Australia
Phone 12872 0
+612 9385 6165
Fax 12872 0
+612 9385 7404
Email 12872 0
d.tilia@ier.org.au
Contact person for scientific queries
Name 3800 0
Daniel Tilia
Address 3800 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 3800 0
Australia
Phone 3800 0
+612 9385 6165
Fax 3800 0
+612 9385 7404
Email 3800 0
d.tilia@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