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Trial registered on ANZCTR


Registration number
ACTRN12609000430235
Ethics application status
Approved
Date submitted
20/05/2009
Date registered
10/06/2009
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, single-masked, cross-over, randomised clinical trial assessing ocular comfort and ocular changes with and without lens replacement during the day with AIR OPTIX (trademark) AQUA contact lenses worn by experienced wearers over three days
Scientific title
A prospective, single-masked, cross-over, randomised clinical trial assessing ocular comfort and ocular changes with and without lens replacement during the day with AIR OPTIX (trademark) AQUA contact lenses worn by experienced wearers over three days
Secondary ID [1] 879 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 4820 0
Ocular Comfort 4824 0
Condition category
Condition code
Eye 237165 237165 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single-masked, cross-over, randomised clinical trial, with participants wearing AIR OPTIX AQUA contact lenses bilaterally over 3 days following initial lens dispense.
Participants will initially be fitted with contact lenses . This is followed by three days of wear with the same lens type. Each day corresponds to one stage of the study. For two of the stages, participants will insert their own study lenses and these will be removed after approximately five hours of wear. Either the same lenses will be re-inserted after a brief soak in saline or a new pair of lenses will be inserted. For the other stage, participants will insert their own study lenses and wear the same lenses for the day without removal. The order in which this occurs will be randomised for all stages and masked when lenses are removed during the day. Subjective responses will also be evaluated at regular intervals during each stage.
It is expected that most participants will have six scheduled visits, comprising the baseline visit followed by two stages with two visits per stage and one stage with one visit.
* Baseline visit
* Stages where lenses removed during the day
o Visit 1
o Visit 2
* Stage where lenses not removed during the day:
o Visit 1
* Take home questionnaires (THQ) at regular intervals during the day for all stages
Intervention code [1] 3439 0
Lifestyle
Intervention code [2] 4591 0
Behaviour
Intervention code [3] 4596 0
Treatment: Devices
Comparator / control treatment
Active control- cross over study
Control group
Active

Outcomes
Primary outcome [1] 237980 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] 237980 0
day 1, 2, 3
Secondary outcome [1] 242104 0
Ocular response. This will assessed with a slit lamp biomicroscope, which is a specialised micrsocope used to view the eye.
Timepoint [1] 242104 0
day 1, 2, 3

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 an experienced contact lens wearer;
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) 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 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.
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
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] 4980 0
Charities/Societies/Foundations
Name [1] 4980 0
Institute for Eye Research
Address [1] 4980 0
Level 5, North Wing, Rupert Myers Building (RMB), Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country [1] 4980 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] 4502 0
None
Name [1] 4502 0
Address [1] 4502 0
Country [1] 4502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7081 0
The Vision CRC and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 7081 0
Level 4, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Ethics committee country [1] 7081 0
Australia
Date submitted for ethics approval [1] 7081 0
26/05/2009
Approval date [1] 7081 0
16/07/2009
Ethics approval number [1] 7081 0
0903

Summary
Brief summary
The aim of this trial is to assess changes in ocular comfort during the day, and whether ocular comfort is influenced by new lens replacement or re-insertion with the same lens after a brief soak in saline, during the day. The trial also aims to assess ocular changes and whether these correlate with changes in comfort.

The hypothesis for this trial is ocular comfort will decrease with lens wear during the day whether lenses are replaced, the same lens is re-inserted or the same lens is worn uninterrupted for the day.
Trial website
Trial related presentations / publications
Papas EB, Tilia D, Tomlinson D, Williams J, Chan E, Chan J, Golebiowski B.
Consequences of wear interruption for discomfort with contact lenses
Optom Vis Sci. 2014 Jan;91(1):24-31
Public notes

Contacts
Principal investigator
Name 28959 0
Mr Daniel Tilia
Address 28959 0
Level 5 RMB
Gate 14 Barker St
UNSW 2052
Country 28959 0
Australia
Phone 28959 0
+61293857516
Fax 28959 0
Email 28959 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 12116 0
Mr Daniel Tilia
Address 12116 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 12116 0
Australia
Phone 12116 0
+61293857516
Fax 12116 0
+61293857404
Email 12116 0
d.tilia@ier.org.au
Contact person for scientific queries
Name 3044 0
Mr Daniel Tilia
Address 3044 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 3044 0
Australia
Phone 3044 0
+61293856165
Fax 3044 0
+61293857404
Email 3044 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