Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000329369
Ethics application status
Not yet submitted
Date submitted
11/07/2008
Date registered
15/07/2008
Date last updated
15/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, open label, multi-block study of currently marketed 'contact lenses' and 'lens care solutions' to evaluate product performance in both experienced & new contact lens wearers.
Scientific title
Prospective, open label, multi-block study of currently marketed 'contact lenses' and 'lens care solutions' to evaluate eye and product performance in both experienced & new contact lens wearers.
Secondary ID [1] 623 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 3330 0
Condition category
Condition code
Eye 3485 3485 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of on-eye performance of marketed contact lenses to establish compatibility with commercially available lens care products (solutions). The comparison will involve evaluation of ocular health, lens performance on-eye and subjective responses with these lenses when used up to 3 months on a daily wear or extended wear and disposal schedule.
A range of 19 different contact lens brands (O2OPTIX [Trade mark], NIGHT & DAY, DAILIES AquaComfort Plus [Registered trade mark], ACUVUE ADVANCE [Trade mark], ACUVUE OASYS [Trade mark], ACUVUE 2 [Registered trade mark],1-DAY ACUVUE, 1-DAY ACUVUE. MOIST [Trade mark], Biofinity, Proclear, SofLens One Day, Biomedics One Day, Day by Day, Clear 1 Day, Gelflex 1 Day, PureVision [Trade mark], Avaira [Trade mark], AIR OPTIX [Trade mark], Aqua, AIR OPTIX Individual [Registered trade mark]),will each be combined with one of six different contact lens solutions (AOSept Plus, AQuify, ReNu MultiPlus, OPTI-FREE EXPRESS, OPTI-FREE RepleniSH, COMPLETE Multi-Purpose Solution Easy Rub [Trade mark] Formula). Each contact lens/solution combination will be administered to a minimum of 40 subjects who are involved in a trial for a period of 3 months. Within this 3 month period, each subject will be wearing only one contact lens brand and solution combination. There can be up to 50 different contact lens/solution combinations trialled over a 5 year period.
Intervention code [1] 3064 0
Treatment: Devices
Intervention code [2] 3075 0
Lifestyle
Comparator / control treatment
There is no control group (multiple intervention groups being compared).
Control group
Active

Outcomes
Primary outcome [1] 4448 0
Primary Outcome: To evaluate the on-eye performance and response of marketed contact lenses and contact lens solutions. The primary outcome will be measured by the evaluation of comfort of lenses on-eye and determination of physiological response to contact lens and contact lens solution combinations.
Timepoint [1] 4448 0
At Baseline, 2 weeks, 1 month, 2 months and 3 months of contact lens wear
Secondary outcome [1] 7520 0
Secondary Outcome 1: To evaluate which combinations of marketed contact lenses and contact lens solutions perform best with each other. This is measured by observing ocular variables including redness, corneal and conjunctival staining.
Timepoint [1] 7520 0
At Baseline, 2 weeks, 1 month, 2 months and 3 months of contact lens wear

Eligibility
Key inclusion criteria
Participants enrolled in the trial must:
- be 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;
- 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;
- have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses on a standard Bailey-Lovie logMAR distance letter chart (For a person to see 6/12 or better, this person needs to be able to distinguish clearly an object at 6 metres away that the 'average' person can distinguish at 12 metres away, 20/40 is the equivalent measurement in feet);
- may be experienced or inexperienced at wearing contact lenses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants enrolled in the trial must NOT have:
- 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;
- A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- 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 or beneficial manner;
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;
- Known allergy to ingredients in contact lens solutions;
- Currently enrolled in another clinical trial;
- Participation in a clinical trial within the previous 2 weeks or participation in an ‘inhouse’ clinical trial within the previous 48 hours;
- Be pregnant*
- Allergy or intolerance to topical anaesthetics

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.

*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Multiple groups - up to 50 trials of different lens/solution combinations with a minimum of 40 subjects in each trial can be run. A subject may participate in more than one trial, however no subject will be enrolled in all trials.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1001 0
2000 - 2249
Recruitment postcode(s) [2] 1002 0
2555 - 2574
Recruitment postcode(s) [3] 1003 0
2740 - 2786

Funding & Sponsors
Funding source category [1] 3534 0
Charities/Societies/Foundations
Name [1] 3534 0
Institute for Eye Research
Country [1] 3534 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CIBA VISION
Address
11460 Johns Creek Parkway
Duluth, GA 30097-1556
USA
Country
United States of America
Secondary sponsor category [1] 3177 0
None
Name [1] 3177 0
Address [1] 3177 0
Country [1] 3177 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5627 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics
Ethics committee address [1] 5627 0
Ethics committee country [1] 5627 0
Australia
Date submitted for ethics approval [1] 5627 0
14/07/2008
Approval date [1] 5627 0
Ethics approval number [1] 5627 0

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

Contacts
Principal investigator
Name 28710 0
Address 28710 0
Country 28710 0
Phone 28710 0
Fax 28710 0
Email 28710 0
Contact person for public queries
Name 11867 0
Jennie Diec
Address 11867 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street
University of New South Wales,
NSW 2052
Country 11867 0
Australia
Phone 11867 0
+61 2 9385 7516
Fax 11867 0
+61 2 93857401
Email 11867 0
[email protected]
Contact person for scientific queries
Name 2795 0
Vicki Evans
Address 2795 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker Street
University of New South Wales,
NSW 2052
Country 2795 0
Australia
Phone 2795 0
+61 2 9385 7516
Fax 2795 0
+61 2 93857401
Email 2795 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.