Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001337561
Ethics application status
Approved
Date submitted
4/12/2015
Date registered
8/12/2015
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial to assess the visual performance of prototype contact lenses for astigmatism
Scientific title
Prospective, single-masked, bilateral wear, crossover, clinical trial to assess visual performance of prototype contact lens designs for astigmatism compared to commercial contact lenses
Secondary ID [1] 288027 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Astigmatism 296894 0
Condition category
Condition code
Eye 297124 297124 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will wear a prototype(test) soft contact lens for astigmatism bilaterally. An optometrist will fit participants with the assigned study lens and check its performance prior to dispensing lenses to participants. Participants will wear each lens for a minimum of 3 days in a week (up to 7 days a week) consistent with the participant's usual amount of contact lens wear. Up to two take home questionnaires will be completed on one time point between days 2-6 (depending on the number of days contact lenses are worn) . Between each lens type, there will be a washout period of 2 nights. To monitor adherence, participants will return unused lenses and foils of used lenses.
Intervention code [1] 293385 0
Treatment: Devices
Comparator / control treatment
There will be two controls. Both are commercially available soft contact lenses. The controls are 1 Day Acuvue Moist (Johnson & Johnson ) and Biofinity Toric (CooperVision). Controls will be worn on a daily wear, daily disposable basis
Control group
Active

Outcomes
Primary outcome [1] 296782 0
Visual Acuity using LogMAR chart
Timepoint [1] 296782 0
Day 0 (at time of dispense) and Day X (assessment visit)
Where 3< X < 7 days.
Primary outcome [2] 296783 0
Contrast sensitivity using Pelli-Robson chart equivalent
Timepoint [2] 296783 0
Day 0 (at time of dispense); Day X (assessment visit)
Where 3< X < 7 days.
Secondary outcome [1] 319335 0
Subjective ratings from participants comparing prototype contact lenses and commercial control using numerical scales
Timepoint [1] 319335 0
Day 0 (at time of dispense); Day X where 0<X<7 (take-home questionnaire); Day 7 (assessment visit)

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.
* Have astigmatism between -0.75 D and -2.00D.
* 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.
* Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
* Be suitable and willing to wear contact lenses
Minimum age
18 Years
Maximum age
40 Years
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, Sjögrens 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. However, ocular medication can be prescribed during the course of the trial as per standard optometric practice.
* 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.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2016
Actual
16/02/2016
Date of last participant enrolment
Anticipated
Actual
11/05/2016
Date of last data collection
Anticipated
Actual
10/06/2016
Sample size
Target
35
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292502 0
Commercial sector/Industry
Name [1] 292502 0
Brien Holden Vision Pty Ltd
Country [1] 292502 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brien Holden Vision Pty Ltd
Address
Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 291211 0
None
Name [1] 291211 0
Address [1] 291211 0
Country [1] 291211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293972 0
Bellberry Limited
Ethics committee address [1] 293972 0
129 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 293972 0
Australia
Date submitted for ethics approval [1] 293972 0
07/12/2015
Approval date [1] 293972 0
27/01/2016
Ethics approval number [1] 293972 0

Summary
Brief summary
This is a clinical trial to assess the visual performance of a new (prototype) soft contact lens for astigmatism compared to commercially available soft contact lenses. Astigmatism is a common eye condition where images at all distances can be blurred to variation in the shape of the surface of the eye. To assess the visual performance we wish to monitor your eyes' response to the products and what you think of them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61866 0
Mr Danny Kho
Address 61866 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 61866 0
Australia
Phone 61866 0
+61 2 9385 7516
Fax 61866 0
Email 61866 0
D.Kho@brienholdenvision.org
Contact person for public queries
Name 61867 0
Mr Danny Kho
Address 61867 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 61867 0
Australia
Phone 61867 0
+61 2 9385 7516
Fax 61867 0
Email 61867 0
D.Kho@brienholdenvision.org
Contact person for scientific queries
Name 61868 0
Mr Danny Kho
Address 61868 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 61868 0
Australia
Phone 61868 0
+61 2 9385 7516
Fax 61868 0
Email 61868 0
D.Kho@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.