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Trial registered on ANZCTR


Registration number
ACTRN12614000776606
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
21/07/2014
Date last updated
10/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Visual performance of prototype contact lens designs.
Scientific title
Prospective, participant-masked, bilateral wear, crossover, clinical trial to assess the visual performance of prototype contact lens designs compared with a commercial contact lens in healthy participants with presbyopia and/or myopia.
Secondary ID [1] 284966 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 292459 0
Myopia 292460 0
Condition category
Condition code
Eye 292774 292774 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The contact lenses being studied are prototype soft contact lenses made from Etafilcon A material. The lenses differ only in their power profile - all are made from the same material. The contact lens powers will range from +3.00 to -6.00D in 0.25 steps for non presbyopes and for presbyopes from +3.00 to -6.00D in 0.25 steps for low, mid and high adds (range from +0.75 to +2.50D).

Participants will test 1 pair of prototype soft contact lenses. Lenses will be inserted bilaterally on the participant by the investigating optometrist, and worn for a maximum of 1 hour. A minimum of an overnight wash out period will be required between the lens visits.
Intervention code [1] 289795 0
Treatment: Devices
Comparator / control treatment
Participants will test one commercially available contact lens as a control. The control lens is Acuvue Oasys for Presbyopia for the presbyopic group and 1-Day Acuvue Moist for the non-presbyopic group. Lenses will be inserted bilaterally on the participant by the investigating optometrist, and worn for a maximum of 1 hour. A minimum of an overnight wash out period will be required between the lens visits.
Control group
Active

Outcomes
Primary outcome [1] 292623 0
To evaluate the visual performance of the prototype contact lens designs compared to the commercial equivalent.

Visual acuity will be assessed at distance and near with a computerised LogMAR chart and an ETDRS 2000 series logarithmic visual acuity chart respectively.
Timepoint [1] 292623 0
Within 1 hour of inserting each lens design.
Secondary outcome [1] 309362 0
Subjective ratings of vision of participants while wearing the contact lenses using a 1-10 scale questionnaire.
Timepoint [1] 309362 0
Within 1 hour of inserting each lens design.

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 7 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.
Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.
Be suitable and willing to wear contact lenses.
Minimum age
7 Years
Maximum age
70 Years
Gender
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 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.

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)
The planned number of participants is 30 per group, which will be recruited by enrolling a minimum of 30 participants in each group. Enrolment will take place over 1 month.

Participants will be screened for general clinical trial suitability by way of a routine eye examination which includes refraction, visual acuity and general eye health. Informed consent will be obtained prior to any clinical trial procedures. Both experienced CL wearers and neophytes (participants with no prior lens wear experience) will be enrolled into lens wear.

Participants will be allocated to a group depending on whether they are a presbyope or non-presbyope. Participants will then be allocated contact lenses based on their refractive error. The order of the contact lens wear will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated from http://www.randomization.com/. The website's second random generator will be usd to create a random permutation of all lens types for each participant. A randomisation list will be generated by the biostatistician and applied through the Clinic Data Management system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Approximately 30 participants per strata are required in order to demonstrate a statistically significant paired difference in the primary objective of 0.1±0.15 LogMAR VA between test and control lens types at the 5% level of significance with 90% power. This sample of 30 will also have 80% power to demonstrate a statistically significant paired difference in the secondary objective of 1±1.8 in subjective vision ratings between test and control lens types at the 5% level of significance. The sample size is adjusted for a 10% drop out rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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
Recruitment postcode(s) [1] 8440 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 289586 0
Other
Name [1] 289586 0
Brien Holden Vision Pty Ltd
Address [1] 289586 0
Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country [1] 289586 0
Australia
Primary sponsor type
Other
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] 288270 0
None
Name [1] 288270 0
Address [1] 288270 0
Country [1] 288270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291330 0
Bellberry Limited
Ethics committee address [1] 291330 0
129 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 291330 0
Australia
Date submitted for ethics approval [1] 291330 0
11/06/2014
Approval date [1] 291330 0
25/07/2014
Ethics approval number [1] 291330 0
2014-06-325

Summary
Brief summary
To assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49886 0
Ms Jiyoon Chung
Address 49886 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney, NSW 2052
Country 49886 0
Australia
Phone 49886 0
+61293857516
Fax 49886 0
+61293857401
Email 49886 0
j.chung@brienholdenvision.org
Contact person for public queries
Name 49887 0
Ms Jiyoon Chung
Address 49887 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney, NSW 2052
Country 49887 0
Australia
Phone 49887 0
+61293857516
Fax 49887 0
+61293857401
Email 49887 0
j.chung@brienholdenvision.org
Contact person for scientific queries
Name 49888 0
Ms Jiyoon Chung
Address 49888 0
Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney, NSW 2052
Country 49888 0
Australia
Phone 49888 0
+61293857516
Fax 49888 0
+61293857401
Email 49888 0
j.chung@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary