ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000063617

Ethics application status

Approved

Date submitted

8/01/2014

Date registered

20/01/2014

Date last updated

20/01/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Visual performance assessment of prototype contact lenses in children and young adults

Scientific title

Prospective, participant-masked, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in children and young adults

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Myopia

Condition category

Condition code

Eye

Normal eye development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Prospective, participant-masked, clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Up to 6 contact lens designs will be assessed against commercial control lens. The 6 lens designs are the top performing designs based on the results of a non-dispensing pilot study, which assesses the short-term visual performance in adults. The designs differ by power variations across the lens surface. It is voluntary for all the participants to complete all six stages and no 'washout' is required between each stage. Participants will wear the lenses on a daily wear, daily disposable basis for up to 7 days before crossing over to the next lens design. Questionnaires will need to be completed on day 2, 4 and 6.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The commercial control lens (AirOptix Aqua single vision, Alcon) will be worn on a daily wear, daily disposable basis for up to 7 days

Control group

Active

Outcomes

Primary outcome [1]

Visual Acuity using LogMAR chart

Timepoint [1]

Day 0 (at time of dispense); Day 7 (assessment visit)

Primary outcome [2]

Contrast Sensitivity using Pelli-Robson chart or equivalent

Timepoint [2]

Day 0 (at time of dispense); Day 7 (assessment visit)

Secondary outcome [1]

Subjective ratings from participants comparing prototype contact lenses and commercial control using numerical scales and Likert scales

Timepoint [1]

Day 0 (at time of dispense); Day 2/4/6 (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 or have a parent / guardian who is able to give informed consent on the participant’s behalf.
*Be between 7 and 18 years old (inclusive), 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.
*Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.

Minimum age

7 Years

Maximum age

18 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, 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 or strabismus surgery.
*Any binocular vision problems which may be exacerbated with the use of the study products or prevent adequate use of the device such as amblyopia, strabismus, excessive phoria and accommodative or convergence difficulties.
*Contraindications to contact lens wear.
*Known allergy or intolerance to ingredients in any of the clinical trial products

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised 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

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

28/01/2014

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Brien Holden Vision Institute

Address [1]

Level 4, North Wing, RMB
Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Brien Holden Vision Institute

Address

Level 4, North Wing, RMB
Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

129 Glen Osmond Rd
Eastwood
South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/12/2013

Ethics approval number [1]

Summary

Brief summary

Myopia (also known as near or short sightedness) is a condition of the eye where objects viewed in the distance appears blurred. Conventional methods of correcting this optical condition include spectacles and contact lenses. The rate of progression of myopia tends to be more rapid in the younger age and high degrees of myopia can lead to complications such as retinal degeneration and detachments, choroidal neovascular membranes and an increased risk of primary open angle glaucoma.

Numerous studies have investigated different contact lens optical designs to correct and potentially treat myopia. One theory in the attempt to reduce myopia progression is to target the stimulus on the peripheral retina. Previous studies have shown that the peripheral retinal stimulus plays a role in myopia progression.  It is now known that peripheral hyperopia, where the stimulus or focus falls behind the retina, can be a trigger for myopia progression. Myopic eyes tend to have peripheral hyperopia and unfortunately the design of conventional spectacles and contact lenses used to correct myopia, actually exacerbates this. 

Thus, in an attempt to minimise myopia progression, the optical design of contact lens should bring the focus from behind the retinal periphery to either on or in front of the retinal periphery. This concept has been tested in contact lenses previously and progression of myopia was found to be 34% less than when wearing spectacles only. Newer optical designs with this concept are required to be tested to enhance the myopic progression effect, however, as the lens designs are novel, myopic participants are required to test the lenses and ensure both vision and subjective acceptance of the lens prior to longer term assessments on the efficacy of these lenses.

Previously conducted clinical studies assessed numerous prototype lenses after short-term (1.5 and 6 hours) lens wear compared to commercially available equivalent contact lenses in adults. The best performing prototype lenses from the short-term trial have been selected for further testing in the current study against the best performing commercial contact lenses for use in children and young adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Pauline Xu

Address

Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 9882

Fax

p.xu@brienholdenvision.org

Contact person for public queries

Name

Elise Roberston

Address

Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 7507

Fax

e.robertson@brienholdenvision.org

Contact person for scientific queries

Name

Pauline Xu

Address

Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 9882

Fax

p.xu@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

Source	Title	Year of Publication	DOI
Embase	Vision Performance and Accommodative/Binocular Function in Children Wearing Prototype Extended Depth-of-Focus Contact Lenses.	2019	https://dx.doi.org/10.1097/ICL.0000000000000570

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically