Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000423910
Ethics application status
Approved
Date submitted
4/03/2020
Date registered
30/03/2020
Date last updated
9/11/2021
Date data sharing statement initially provided
30/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare two daily disposable contact lenses.
Scientific title
Prospective, double-masked, randomised, parallel, bilateral wear dispensing clinical trial to compare the clinical performance of two daily disposable contact lenses.
Secondary ID [1] 300656 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractive error 316445 0
Condition category
Condition code
Eye 314697 314697 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two silicone hydrogel daily disposable contact lenses will be compared to assess visual performance, lens comfort and handling. The test lens has a water content of 43% with a centre thickness of 0.07mm (-3.00D) and the control lens has a water content of 56% with a centre thickness of 0.03mm (-3.00D). Study participants will be randomly allocated to wear the test or control lens, which they will wear for 30 days. There will be 3 visits. Visit #1, the baseline and initial assessment visit; Visit #2, the entry visit and Visit #3, 30 days after Visit #2, the exit visit. All visits are 1 hour in length. Lens are on a daily wear basis for 30 days with comfort and vision assessed at all visits and between visits. Lens wearing compliance will be confirmed by participants returning lens blister packaging at Visit #3. Participants and investigators will be masked from the lens type worn.
Intervention code [1] 316984 0
Treatment: Devices
Comparator / control treatment
The test and control lenses are both commercially available lens designs.
Control group
Active

Outcomes
Primary outcome [1] 323037 0
Visual Acuity - subjective assessment measured on LogMAR visual acuity charts.
Timepoint [1] 323037 0
To be completed at Baseline visit, Visit 2 (Day 0) and Visit 3 (Day 30).
Secondary outcome [1] 380586 0
Subjective ranking of vision, comfort and lens handling - Using the Numerical Ranked Symptom Scale.
Timepoint [1] 380586 0
Completed at Baseline visit, visit 2 (Day 0 and following 30 mins from lens insertion ), At-home (day 1, 7, 15, 29) and visit 3 (Day 30).
Secondary outcome [2] 380587 0
Objective assessment of lens on eye and physiological responses to lens (Composite outcome) by use of 1-10 ratings scales for lens comfort, vision and handling (0.1 steps)
Timepoint [2] 380587 0
Completed at baseline, visit 2 (Day 0) and visit 3 (Day 30).

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.
* 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.
* Spherical prescription range of -10.00DS to +6.00DS and cylinder less than or equal to 0.75DC)
* Correctable to at least 6/7.5 (20/25) or better in each eye with contact lenses.
* Must be an experienced contact lens wearer.
* Be able to insert and remove contact lenses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any pre-existing ocular irritation, injury or condition (including infection or inflammation) 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.
* Currently enrolled in another clinical trial impacting ocular health, vision or systemic conditions/medications (as noted above), which may impact habitual ocular health and vision and the ability to perform the relevant testing required for the current clinical trial.
* Pregnancy.
* The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfill 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)
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
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimum sample size is estimated for the primary outcome of the study. A minimum of 35 participants per lens type are required in order to demonstrate a statistically significant group difference of 0.10±0.13 logMAR visual acuity between the two lens types. The sample size is estimated at the 5% level of significance with 80% power and accounts for a 15% drop out rate. The difference of 0.1 logMAR correspond to clinically significant levels. The standard deviations correspond to the largest expected SD based on similar trials done in the past.Data stored in relational databases will be imported into SPSS / STATA software for statistical purposes. Data will be investigated for quality using range checks and frequency distribution. Underlying distributions of variables will be tested. In general, variables measured on an interval scale with a sufficiently large sample size will be considered to follow a normal distribution. Outputs from the statistical analysis such as statistical tables will be copied over to Excel. Graphs will generally not be created from the statistical software. All statistical results will be reported in Excel format.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2020
Actual
13/08/2020
Date of last participant enrolment
Anticipated
Actual
9/01/2021
Date of last data collection
Anticipated
Actual
3/03/2021
Sample size
Target
70
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305079 0
Commercial sector/Industry
Name [1] 305079 0
Hope Vision Co., Ltd.
Country [1] 305079 0
Taiwan, Province Of China
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 305452 0
None
Name [1] 305452 0
Address [1] 305452 0
Country [1] 305452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305471 0
Bellberry
Ethics committee address [1] 305471 0
Ethics committee country [1] 305471 0
Australia
Date submitted for ethics approval [1] 305471 0
10/03/2020
Approval date [1] 305471 0
04/06/2020
Ethics approval number [1] 305471 0
2020-03-253

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

Contacts
Principal investigator
Name 100482 0
Dr Craig Woods
Address 100482 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 100482 0
Australia
Phone 100482 0
+61 2 9385 7516
Fax 100482 0
Email 100482 0
c.woods@bhvi.org
Contact person for public queries
Name 100483 0
Shinam Garg
Address 100483 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 100483 0
Australia
Phone 100483 0
+61290650725
Fax 100483 0
Email 100483 0
s.garg@bhvi.org
Contact person for scientific queries
Name 100484 0
Craig Woods
Address 100484 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 100484 0
Australia
Phone 100484 0
+61 2 9385 7516
Fax 100484 0
Email 100484 0
c.woods@bhvi.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.