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Trial registered on ANZCTR


Registration number
ACTRN12610000774022
Ethics application status
Approved
Date submitted
15/09/2010
Date registered
16/09/2010
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of ocular comfort and physiological ocular changes in symptomatic and non-symptomatic contact lens wearers
Scientific title
A prospective, multiple group, cross-over bilateral, double-masked clinical trial assessing ocular comfort and ocular changes in symptomatic and non-symptomatic contact lens wearers when using two commercially-available contact lens/solution combinations
Secondary ID [1] 252704 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 258195 0
Ocular comfort 258196 0
Condition category
Condition code
Eye 258372 258372 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multiple-group, cross over, bilateral, double-masked clinical trial. Participants will use 2 combinations of lens/solution: ACUVUE ADVANCE/AQuify and PureVision/OPTI-FREE RepleniSH for seven consecutive days on a daily wear basis commencing the day after initial lens dispense. Visits will take place on day 1 and 8 of lens wear with each combination, and a minimum wash-out period of 48 hours will apply between each lens/solution combination.
Intervention code [1] 257211 0
Treatment: Devices
Comparator / control treatment
Active control- cross over study
Control group
Active

Outcomes
Primary outcome [1] 259214 0
Ocular comfort as measured by subjective ratings:
This will involve a 1-10 Numeric Rating Scale (NRS) in steps of 0.1, where 1 = extreme discomfort and 10 = no discomfort, and a 2 point Visual Analogue Scale (VAS) where the midpoint corresponds to comfort without contact lens, the lower end of the scale is described as 'unbearable' and the upper end is left open
Timepoint [1] 259214 0
Days 1, 2, 5, 6, 8 of each treatment arm
Secondary outcome [1] 265621 0
Ocular response. this will be assessed with a slit lamp biomicroscope, which is a specialised microscope used to view the eye
Timepoint [1] 265621 0
Days 1 and 8 of each treatment arm

Eligibility
Key inclusion criteria
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;
Has vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Have participated in at least one of previous matrix trials (ANZCTR #: 12608000329369) and satisfy criteria for 'symptomatic' or 'non-symptomatic'. The definitions of 'symptomatic' or 'non-symptomatic' below are based solely on a participant's experience in previous matrix trials:
Symptomatic contact lens wearers are defined as participants who have experienced a one point decrease or more in end-of-day ocular comfort compared to comfort-on-insertion at three scheduled visits.
Non-symptomatic contact lens wearers will be classified as either 'primary' or 'secondary'. Secondary wearers will only be used if insufficient numbers are available from primary wearers:
Primary wearers: participants who have experienced a less than one point decrease in end-of-day ocular comfort compared to comfort-on-insertion at three scheduled visits.
Secondary wearers: participants who have not experienced a one point decrease or more in end-of-day ocular comfort compared to comfort-on-insertion at any scheduled visit, provided at least two visits were attended.
Participants who have completed two or more matrix trials and satisfy the definition for both symptomatic and non-symptomatic wearers will be excluded from this trial.
Minimum age
18 Years
Maximum age
No limit
Sex
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, Sjogrens 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 up to 12 weeks prior to and during the trial;
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;
Be pregnant;

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2010
Actual
17/10/2010
Date of last participant enrolment
Anticipated
Actual
27/05/2011
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] 257663 0
Charities/Societies/Foundations
Name [1] 257663 0
Brien Holden Vision Institute
Country [1] 257663 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
Country
Australia
Secondary sponsor category [1] 256879 0
None
Name [1] 256879 0
Address [1] 256879 0
Country [1] 256879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259681 0
VIHEC Human Research Ethics Committe
Ethics committee address [1] 259681 0
Ethics committee country [1] 259681 0
Australia
Date submitted for ethics approval [1] 259681 0
17/08/2010
Approval date [1] 259681 0
12/10/2010
Ethics approval number [1] 259681 0
10/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31649 0
Mr Daniel Tilia
Address 31649 0
Level 5, North Wing, Rupert Myers Building Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 31649 0
Australia
Phone 31649 0
+61293857404
Fax 31649 0
Email 31649 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 14896 0
Daniel Tilia
Address 14896 0
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 14896 0
Australia
Phone 14896 0
+61293856165
Fax 14896 0
+61293857404
Email 14896 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 5824 0
Daniel Tilia
Address 5824 0
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 5824 0
Australia
Phone 5824 0
+61293856165
Fax 5824 0
+61293857404
Email 5824 0
d.tilia@brienholdenvision.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.