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Trial registered on ANZCTR


Registration number
ACTRN12618001901291
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
22/11/2018
Date last updated
18/09/2019
Date data sharing statement initially provided
22/11/2018
Date results information initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of of different contact lens designs on contact lens dissatisfaction from binocular vision disorders in non-presbyopic adult contact lens wearers.
Scientific title
Prospective, double-masked, randomized, crossover, bilateral wear dispensing trial to assess the effect of lens design on contact lens dissatisfaction in symptomatic, pre-presbyopic, contact lens wearers with a binocular vision order and / or contact lens discomfort.
Secondary ID [1] 296652 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 310476 0
Binocular vision disorder 310477 0
Contact lens discomfort 310478 0
Condition category
Condition code
Eye 309190 309190 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial.
Participants will wear three contact lens designs for two weeks each on a single-use, daily wear basis with a minimum 13 day wash-out between lens types. All contact lenses are made from etafilcon A material. One design contains a near addition (base curve 8.4, diameter 14.3, medium addition), one design has an extended depth of focus profile created by selective manipulation of multiple, spherical aberration terms (base curve 8.5, diameter 14.2, extended-depth-of-focus 0.75 D) and one lens has a flat peripheral optical profile (base curve 8.5, diameter 14.2). All lenses are available in distance power range -0.75 to -6.00 D.
All lenses will be worn on daily-wear, daily disposable basis for about 2 weeks. The minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn, with no maximum wearing time provided lenses are not slept in overnight. A minimum 13 day wash-out will be observed between lens types.
There will 7 visits comprising Baseline and two visits for each of the three lens designs (Fitting and Assessment visits).
All visits will be performed by a masked investigator and will be approximately 60 minutes in duration. Baseline visits will comprise completion of three validated questionnaires (ocular surface disease index [OSDI], convergence insufficiency syndrome survey [CISS], contact lens dry eye questionnaire-8 [CLDEQ-8]), visual acuity assessment and accommodative-convergence responses with habitual contact lenses. Auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye) will be performed with no contact lens on eye. Fitting visits will comprise completion of three validated questionnaires (OSDI, CISS, CLDEQ-8), visual acuity assessment and accommodative-convergence responses with habitual contact lenses. Ocular assessment will be performed with a slit-lamp biomicroscope and visual acuity will be assessed with power-matched study lenses. Assessment visits will comprise completion of three validated questionnaires (OSDI, CISS, CLDEQ-8), visual acuity assessment and accommodative-convergence responses with study contact lenses. Ocular assessment will be performed with a slit-lamp biomicroscope.
Participants will wear their habitual vision correction in between wearing study lens wear. All study contact lenses will be prescribed and all assessments will be carried out by an optometrist.
Participants will be instructed to bring all unused contact lenses to each Assessment visit. Compliance will be assessed by comparing the number of lenses dispensed to the number of unused lenses, as well as verbal questioning of the participant.
Intervention code [1] 312957 0
Treatment: Devices
Comparator / control treatment
Single vision contact lenses with a flat peripheral optical profile and made from etafilcon A material.
Control group
Active

Outcomes
Primary outcome [1] 308168 0
Difference in ocular surface disease index (OSDI) score between habitual and study contact lens
Timepoint [1] 308168 0
Assessment visit 1 (approximately 2 weeks post-enrolment)
Assessment visit 2 (approximately 6 weeks post-enrolment)
Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [1] 354127 0
Difference in the binocular vision profile between habitual and study contact lens. The binocular vision profile is a composite secondary outcome, and comprises:
Dissociated heterophorias at 3 m and 40 cm (Modified Thorington)
Fixation disparity at 40 cm (Saladin)
Accommodative facility at 40 cm (+/-2.00 flip spheres)
Near point of accommodation (Royal Air Force Ruler)
Near point on convergence (red / green goggles and pen torch)
Stereopsis at 40 cm (Random Dot Stereo Acuity test)
Fusional reserves at 6 m and 40 cm (standard phoroptor)
Positive and negative relative accommodation at 40 cm (standard phoroptor)
Accommodative response (open field auto-refractor)
Timepoint [1] 354127 0
Assessment visit 1 (approximately 2 weeks post-enrolment)
Assessment visit 2 (approximately 6 weeks post-enrolment)
Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [2] 354128 0
Difference in convergence insufficiency syndrome survey (CISS) score between habitual and study contact lens
Timepoint [2] 354128 0
Assessment visit 1 (approximately 2 weeks post-enrolment)
Assessment visit 2 (approximately 6 weeks post-enrolment)
Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [3] 354129 0
Difference in contact lens dry eye questionnaire-8 (CLDEQ-8) score between habitual and study contact lens
Timepoint [3] 354129 0
Assessment visit 1 (approximately 2 weeks post-enrolment)
Assessment visit 2 (approximately 6 weeks post-enrolment)
Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [4] 354448 0
Differences in vision clarity at distance between study contact lenses as assessed via a numeric rating scale (1-100 in 1-point steps).
Timepoint [4] 354448 0
Assessment visit 1 (approximately 2 weeks post-enrolment) Assessment visit 2 (approximately 6 weeks post-enrolment) Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [5] 354449 0
Differences in vision clarity at intermediate between study contact lenses as assessed via a numeric rating scale (1-100 in 1-point steps).
Timepoint [5] 354449 0
Assessment visit 1 (approximately 2 weeks post-enrolment) Assessment visit 2 (approximately 6 weeks post-enrolment) Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [6] 354450 0
Differences in vision clarity at near between study contact lenses as assessed via a numeric rating scale (1-100 in 1-point steps).
Timepoint [6] 354450 0
Assessment visit 1 (approximately 2 weeks post-enrolment) Assessment visit 2 (approximately 6 weeks post-enrolment) Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [7] 354451 0
Differences in vision when driving between study contact lenses as assessed via a numeric rating scale (1-100 in 1-point steps).. Change made prior to any enrollment.
Timepoint [7] 354451 0
Assessment visit 1 (approximately 2 weeks post-enrolment) Assessment visit 2 (approximately 6 weeks post-enrolment) Assessment visit 3 (approximately 10 weeks post-enrolment)
Secondary outcome [8] 354452 0
Differences in vision satisfaction between study contact lenses as assessed via a numeric rating scale (1-100 in 1-point steps)..
Timepoint [8] 354452 0
Assessment visit 1 (approximately 2 weeks post-enrolment) Assessment visit 2 (approximately 6 weeks post-enrolment) Assessment visit 3 (approximately 10 weeks post-enrolment)

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be between 18-40 years old, male or female.
Willing to comply with the clinical trial 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.
Be an experienced soft contact lens wearer.
Be myopic with less than or equal to 1.00 D of cylindrical power in either eye.
Be correctable to better than 0.20 logMAR in each eye with single vision contact lenses.
Be able to insert and remove contact lenses.
Score greater than or equal to 15 on the OSDI questionnaire at baseline, while wearing habitual contact lenses.
BVD Group: Have a binocular vision disorder profile at baseline, while wearing habitual contact lenses
CLD Group: Score greater than or equal to 12 on the CLDEQ-8 but not have a binocular vision disorder profile at baseline, while wearing habitual contact lenses.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.
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 while wearing study lenses.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Previous surgery on the extra ocular muscles.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Pregnancy*.
The Investigator may, at his discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or 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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created through www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: A recent clinical trial found the mean +/- SD in OSDI scores in participants with a binocular vision disorder (BVD) equals 24.8 +/- 12.7, and the cut-off score on the OSDI for being regarded as symptomatic CL wearer equals 15. Therefore, a minimum of 22 participants with a BVD are required in order to demonstrate a statistically significant paired difference of 9.8 + / - 12.7 on the OSDI questionnaire at the 5% level of significance and 80% power. The sample size is adjusted for a 10% dropout rate.
A minimum of 22 participants with contact lens discomfort but no BVD will also be recruited, giving a total minimum sample size of 44.
Primary endpoint: OSDI will be scored as per published instructions. Data will be summarised as means +/- standard deviations. Data transformation will be performed prior to analysis if required. OSDI scores will be compared between each lens design and control lens types. The significance of the lens designs will be determined for each visit using repeated effects linear mixed model with subject random intercepts which accounts for the repeated effects within a participant. If the overall effect is significant, post hoc multiple comparisons will be adjusted using Bonferroni correction.
Secondary endpoints: Questionnaires will be scored as per published instructions. Binocular vision profile assessment will be recorded using standard optometric nomenclature. Data transformation will be performed prior to analysis if required. Variables will be compared between the various lens types. The significance of the lens designs will be determined using repeated effects linear mixed model with subject random intercepts which accounts for the repeated effects within a participant. If the overall effect is significant, post hoc multiple comparisons will be adjusted using Bonferroni correction.

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

Funding & Sponsors
Funding source category [1] 301229 0
Charities/Societies/Foundations
Name [1] 301229 0
Brien Holden Vision Institute
Address [1] 301229 0
Level 4, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country [1] 301229 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 300863 0
None
Name [1] 300863 0
Address [1] 300863 0
Country [1] 300863 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301972 0
Bellberry Limited
Ethics committee address [1] 301972 0
129 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 301972 0
Australia
Date submitted for ethics approval [1] 301972 0
07/12/2018
Approval date [1] 301972 0
02/01/2019
Ethics approval number [1] 301972 0

Summary
Brief summary
The purpose of this trial is to assess the effect of lens design on contact lens dissatisfaction in symptomatic, pre-presbyopic, CL wearers with a binocular vision disorder and / or contact lens discomfort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88722 0
Mr Daniel Tilia
Address 88722 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 88722 0
Australia
Phone 88722 0
+61293857516
Fax 88722 0
Email 88722 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 88723 0
Mr Daniel Tilia
Address 88723 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 88723 0
Australia
Phone 88723 0
+61293857516
Fax 88723 0
Email 88723 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 88724 0
Mr Daniel Tilia
Address 88724 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 88724 0
Australia
Phone 88724 0
+61293857516
Fax 88724 0
Email 88724 0
d.tilia@brienholdenvision.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not published. However trial results, recorded as group means plus/minus
SD and their statistical analysis may be published in scientific journals or conferences.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary