Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000187842
Ethics application status
Approved
Date submitted
8/02/2012
Date registered
13/02/2012
Date last updated
13/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the subjective comfort of DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] in twenty-five experienced contact lens wearers.
Scientific title
Prospective, single-masked, randomised, contralateral investigation comparing DAILIES TOTAL 1[RegisteredTradeMark] to ACUVUE[RegisteredTradeMark] OASYS[TradeMark] on subjective comfort with twenty-five myopic participants.
Secondary ID [1] 279898 0
Nil
Universal Trial Number (UTN)
U1111-1128-0283
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular comfort/discomfort 285808 0
Condition category
Condition code
Eye 285985 285985 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the Baseline visit, if participants has attended with a 2 days of no lens wear period, they are fitted with both the DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] lenses as per the randomisation for eyes (different lens on each eye). After 8 hours of lens wear, participants are to return for ocular health exams and lenses are removed and discarded. After 2 days of washout period, they are asked to return for Stage 2 dispensing visit where they will be dispensed the DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] lenses. At this visit, the randomisation of the lenses to the eyes will be swapped (ie. if DAILES TOTAL1 worn on right eye in Stage 1, it would be ACUVUE OASYS worn on right eye in Stage 2). Ocular health and subject comfort rating questionnaires are completed at Baseline, 8 hours after lens wear, Stage 2 Dispensing and 8 hours after lens wear (Stage 2)
Intervention code [1] 284226 0
Treatment: Devices
Comparator / control treatment
ACUVUE[RegisteredTradeMark] OASYS[TradeMark]
Control group
Active

Outcomes
Primary outcome [1] 286479 0
Subjective comfort ratings measured with Numeric Rating Scale of 1 to 10.
Timepoint [1] 286479 0
Baseline (Stage 1 Dispensing), 8 hours after lens wear, Stage 2 (Dispensing), and 8 hours after lens wear (Stage 2)
Secondary outcome [1] 295975 0
Nil
Timepoint [1] 295975 0
Nil

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, male or female.
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 experienced in wearing contact lenses.
Be able to insert and remove contact lenses.
Be willing to not wear contact lenses for at least 48 hours before each stage of the clinical trial (after informed consent).
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 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, Sjogrens syndrome and systemic lupus erythematosus. 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 at enrolment and/or during the clinical 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 at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
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.
Pregnancy

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)
Once participant passes all inclusion/exclusion criteria, they are considered enrolled after signing the informed consent form. The participants will be masked to which lens type is in which eye. They will also be masked to the fact that the randomisation of the eyes will be swapped at Stage 2. Participants will be masked to the lenses either by the Investigator inserting the lenses or by the lenses being dispensed to the participant in a lens case to remove the original packaging. Investigators will also be removing the contact lenses at the 8 Hour Visit. Allocation concealment was done with central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will have randomisation of the lens type to eye (right / left) applied during this study. The randomisation will then be swapped at Stage2 Dispensing. Simple randomisation by using a randomisation table created by computer software was performed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
contralateral (one eye control, one eye test)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284673 0
Charities/Societies/Foundations
Name [1] 284673 0
Brien Holden Vision Institute
Country [1] 284673 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] 283578 0
None
Name [1] 283578 0
Address [1] 283578 0
Country [1] 283578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286677 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 286677 0
Ethics committee country [1] 286677 0
Australia
Date submitted for ethics approval [1] 286677 0
05/01/2012
Approval date [1] 286677 0
27/01/2012
Ethics approval number [1] 286677 0
2011-12-586

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

Contacts
Principal investigator
Name 33748 0
Address 33748 0
Country 33748 0
Phone 33748 0
Fax 33748 0
Email 33748 0
Contact person for public queries
Name 16995 0
Jennie Diec
Address 16995 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 16995 0
Australia
Phone 16995 0
+61 2 9385 7516
Fax 16995 0
+61 2 9385 7401
Email 16995 0
[email protected]
Contact person for scientific queries
Name 7923 0
Jennie Diec
Address 7923 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 7923 0
Australia
Phone 7923 0
+61 2 9385 7516
Fax 7923 0
+61 2 9385 7401
Email 7923 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.