Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000639022
Ethics application status
Approved
Date submitted
4/08/2010
Date registered
5/08/2010
Date last updated
5/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Contralateral, cross over clinical trial to assess the effect of novel and commercially available contact lenses on corneal topography
Scientific title
A prospective, open-label, contralateral daily wear, cross over, randomised clinical trial assessing the effect of wearing a novel and five commercially available contact lenses for 1 week on corneal topography worn in experienced myopic contact lens wearers
Secondary ID [1] 252195 0
nil
Universal Trial Number (UTN)
Trial acronym
Corneal Topography
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Wear
Corneal Topography 257728 0
Condition category
Condition code
Eye 257902 257902 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 Commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, AIR OPTIX [Trade mark] Aqua Multifocal, NIGHT & DAY [Registered trade mark], ACUVUE 2 [Trade mark], Avaira [Trade mark])and 1 novel optical design silicone hydrogel contact lens have been chosen as test products to examine the effect of modulus and lens design on corneal topography after 1 week of wear. The novel optical design is manufactured from the same material as AIR OPTIX [trademark] Aqua and has a different optical power distribution in the lens periphery. Contact lenses are suitable to be worn for 2 weeks, however, the 6 types of contact lenses will each be worn on a daily basis for approximately 1 week. Contact lens designs will be dispensed contralaterally by randomisation. Between each change of contact lens design contact lenses may not be worn for 1 calendar day, "1 day washout period", prior to each dispensing visit.
Intervention code [1] 256790 0
Treatment: Devices
Comparator / control treatment
The control will be the corneal topographical map captured prior to each lens dispense after 1 calendar day of no contact lens wear.
Control group
Active

Outcomes
Primary outcome [1] 258765 0
To determine the effect of contact lenses on corneal topography in a myopic population after 8 hours and 1 week of contact lens (CL) wear.
Timepoint [1] 258765 0
Baseline, 1 week, 2 weeks, 3 weeks of contact lens wear
Secondary outcome [1] 264824 0
1) To determine the effect on peripheral refraction profiles during contact lens wear with the use of a modified Shin Nippon N-Vision K5001 Autorefractor.
2) To determine axial length after 1 week of CL wear in a small myopic population as determined by an IOL Master optical biometer.
Timepoint [1] 264824 0
Baseline, 1 week, 2 weeks, 3 weeks of contact lens wear

Eligibility
Key inclusion criteria
- be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. If participant is a child or adolescent, a parent or legal guardian must be able to provide this consent,
- be between the ages of 18 and 45 years old inclusive
- be myopic (short sighted) -0.75D to -4.25D with astigmatism no more than -1.00 D
- 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.
- be experienced wearing contact lenses
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pre-existing ocular irritation that would preclude contact lens fitting;
- Strabismus or amblyopia;
- Any ocular condition that may preclude safe wearing of contact lenses (e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy);
- Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal oedema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses;
- Any systemic disease that may adversely affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- Previous corneal refractive surgery;
- Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
- Contraindications to hydrogel contact lens wear;
- Worn orthokeratology lenses within the past 3 months;
- Currently enrolled in another clinical trial;
- Pregnancy (verbal report from participant will suffice).

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
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257275 0
Charities/Societies/Foundations
Name [1] 257275 0
Brien Holden Vision Institute
Country [1] 257275 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CIBA VISION Corporation
Address
Continuous Wear Category R&D
11460 John Creek Parkway
Duluth, Atlanta GA 30097-1556, USA
Country
United States of America
Secondary sponsor category [1] 256518 0
None
Name [1] 256518 0
Address [1] 256518 0
Country [1] 256518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259301 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 259301 0
Level 4, North Wing,
Rupert Myers Building (RMB)
Gate 14, Barker Street
The University of New South Wales SYDNEY, NSW 2052, AUSTRALIA
Ethics committee country [1] 259301 0
Australia
Date submitted for ethics approval [1] 259301 0
17/06/2010
Approval date [1] 259301 0
04/08/2010
Ethics approval number [1] 259301 0
1/07/2010

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

Contacts
Principal investigator
Name 31383 0
Address 31383 0
Country 31383 0
Phone 31383 0
Fax 31383 0
Email 31383 0
Contact person for public queries
Name 14630 0
Judy Kwan
Address 14630 0
Level 5 North Wing
Rupert Myers Building
Gate 14 Barker St
UNSW Sydney NSW 2052
Country 14630 0
Australia
Phone 14630 0
+61 2 9385 7516
Fax 14630 0
Email 14630 0
[email protected]
Contact person for scientific queries
Name 5558 0
Judy Kwan
Address 5558 0
Level 5 North Wing
Rupert Myers Building
Gate 14 Barker St
UNSW Sydney NSW 2052
Country 5558 0
Australia
Phone 5558 0
+61 2 9385 7516
Fax 5558 0
Email 5558 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.