Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000640202
Ethics application status
Approved
Date submitted
28/07/2009
Date registered
30/07/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, open-label, daily wear, parallel group, randomised clinical trial assessing an investigational contact lens care solution for comfort, safety and efficacy with four commercially available contact lenses, worn bilaterally over three months, in both experienced and new contact lens wearers
Scientific title
A prospective, open-label, daily wear, parallel group, randomised clinical trial assessing an investigational contact lens care solution for comfort, safety and efficacy with four commercially available contact lenses, worn bilaterally over three months, in both experienced and new contact lens wearers
Secondary ID [1] 252706 0
None
Universal Trial Number (UTN)
Trial acronym
AMO 3 month trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 237340 0
Contact lens care solution 237341 0
Condition category
Condition code
Eye 239662 239662 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing one of 4 commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, NIGHT & DAY [Registered trade mark], ACUVUE OASYS [Trade mark], PureVision [Trade mark]) in conjunction with an investigational contact lens care solution over a 3 month period on a daily wear basis.
Participants will be randomised to wear one of 4 commercially available contact lenses. There are visits at 2 weeks, 1 month and 3 months from initial lens fitting. Contact lens cases will be collected at the 1 month and 3 months visits for analysis.
each contact lens group will have a minimum of 40 participants.
Intervention code [1] 237003 0
Treatment: Devices
Intervention code [2] 237004 0
Lifestyle
Comparator / control treatment
The control for the outcomes of ocular comfort and ocular response will be standard care, while historical data will be used for the contact lens contamination outcome
Control group
Active

Outcomes
Primary outcome [1] 238438 0
Subjective ocular comfort with various lenses and investigational contact lens care solution. Subjective ocular comfort will be measured via questionnaire
Timepoint [1] 238438 0
Baseline, 2 weeks, 1 month and 3 months of contact lens wear
Secondary outcome [1] 244939 0
Ocular response with various lenses and investigational contact lens care solution. Ocular response will be measured using a slit-lamp biomicroscope.
Timepoint [1] 244939 0
Baseline, 2 weeks, 1 month and 3 months of contact lens wear
Secondary outcome [2] 244940 0
Contamination rate of contact lens cases used with investigational solution compared to historical data. The historical data consists of data collected from previous clinical trials run at the Institute for Eye Research from 2005-2009
Timepoint [2] 244940 0
1 month and 3 months of contact lens wear

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;
-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
-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 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 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 beneficial manner at enrolment and/or during the study;
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 or intolerance to ingredients in any of the study 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*;

The Investigator may, at his/her discretion, exclude anyone 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
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237387 0
Charities/Societies/Foundations
Name [1] 237387 0
Institute for Eye Research
Country [1] 237387 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Abbott Medical Optics, Inc
Address
1700 East St. Andrew Place
PO Box 25162
Santa Ana, CA 92799-5162, USA
Country
United States of America
Secondary sponsor category [1] 236887 0
None
Name [1] 236887 0
Address [1] 236887 0
Country [1] 236887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239519 0
The Vision Cooperative Research Centre (CRC) and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 239519 0
Ethics committee country [1] 239519 0
Australia
Date submitted for ethics approval [1] 239519 0
27/07/2009
Approval date [1] 239519 0
23/09/2009
Ethics approval number [1] 239519 0
09/24

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

Contacts
Principal investigator
Name 29955 0
Address 29955 0
Country 29955 0
Phone 29955 0
Fax 29955 0
Email 29955 0
Contact person for public queries
Name 13202 0
Daniel Tilia
Address 13202 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 13202 0
Australia
Phone 13202 0
+612 9385 6165
Fax 13202 0
+612 9385 7404
Email 13202 0
d.tilia@ier.org.au
Contact person for scientific queries
Name 4130 0
Daniel Tilia
Address 4130 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 4130 0
Australia
Phone 4130 0
+612 9385 6165
Fax 4130 0
Email 4130 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.