Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000812291
Ethics application status
Approved
Date submitted
16/09/2009
Date registered
17/09/2009
Date last updated
31/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, open labelled, randomised daily wear trial comparing the ocular response and product performance between 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys contact lenses in new and experienced wearers
Scientific title
Prospective, open labelled, randomised daily wear trial comparing the ocular response and product performance between 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys contact lenses in new and experienced wearers
Secondary ID [1] 1102 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 243857 0
Condition category
Condition code
Eye 240033 240033 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of on eye performance of three marketed contact lenses used on a daily wear schedule. The contact lenses tested include 1 Day Acuvue Moist, 1 Day Acuvue Trueye and Acuvue Oasys. The trial will last for three months and the performance of the lenses on eye and subjective responses will be assessed.
Intervention code [1] 241297 0
Treatment: Devices
Comparator / control treatment
There is no control group, all three lenses are tested and compared with each other
Control group
Active

Outcomes
Primary outcome [1] 240932 0
Primary outcome: To evaluate the effect of lens wear on the ocular surface with 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys by observing physiological variables including corneal staining.
Timepoint [1] 240932 0
At the baseline visit, 2 week, 1 month and 3 month visits
Secondary outcome [1] 257652 0
Secondary outcome: To evaluate the on eye performance of 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys by observing ocular physiological variables such as redness, contact lens variables such as lens fit and subjective variables with questionnaires.
Timepoint [1] 257652 0
At the baseline visit, 2 week, 1 month and 3 month visits

Eligibility
Key inclusion criteria
Participants in this 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;
- Has vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- 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 in this 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;
- 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 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;
- Currently enrolled in another clinical trial;
- Participation in a clinical trial within the previous 2 weeks or participation in a ‘short term’ clinical trial within the previous 48 hours;
- Be pregnant
- Allergy or intolerance to topical anaesthetics

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be generated from simple randomisation using randomisation computer software.
Masking / blinding
Open (masking not 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
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2113 0
2000 - 2249
Recruitment postcode(s) [2] 2114 0
2555 - 2574

Funding & Sponsors
Funding source category [1] 243752 0
Charities/Societies/Foundations
Name [1] 243752 0
Institute for Eye Research
Country [1] 243752 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Alcon Laboratories
Address
6201 South Freeway, Fort Worth, Texas 76134
Country
United States of America
Secondary sponsor category [1] 237108 0
None
Name [1] 237108 0
Address [1] 237108 0
Country [1] 237108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243881 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics
Ethics committee address [1] 243881 0
Vision CRC Ltd, Lvl 4, RMB, Gate 14, Barker St, UNSW, Kensington 2052
Ethics committee country [1] 243881 0
Australia
Date submitted for ethics approval [1] 243881 0
23/09/2009
Approval date [1] 243881 0
Ethics approval number [1] 243881 0

Summary
Brief summary
To observe on eye performance of three marketed contact lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30296 0
Address 30296 0
Country 30296 0
Phone 30296 0
Fax 30296 0
Email 30296 0
Contact person for public queries
Name 13543 0
Jennie Diec
Address 13543 0
Lvl 5, RMB, North Wing, Gate 14, Barker St, UNSW, Kensington 2052
Country 13543 0
Australia
Phone 13543 0
+612 9385 7516
Fax 13543 0
Email 13543 0
[email protected]
Contact person for scientific queries
Name 4471 0
Jennie Diec
Address 4471 0
Lvl 5, RMB, North Wing, Gate 14, Barker St, UNSW, Kensington 2052
Country 4471 0
Australia
Phone 4471 0
+612 9385 7516
Fax 4471 0
Email 4471 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.