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Trial registered on ANZCTR


Registration number
ACTRN12621001399886
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
18/10/2021
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare prototype ophthalmic lenses and commercially available ophthalmic lenses -Part 2 0f 2..
Scientific title
A phased prospective, bilateral wear clinical trial to compare the visual
performance and wearability of prototype ophthalmic lenses and
commercially available myopia control spectacles among the age group of 18 to 35 years (The Calvin Study-part 2 of 2).
Secondary ID [1] 305340 0
CRTC2019-06
Universal Trial Number (UTN)
Trial acronym
The Calvin Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 323666 0
Condition category
Condition code
Eye 321209 321209 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized single-masked (participant) crossover study design. Participants will attend for two study visits for each of the three lens designs (two prototypes and one control lens design). Each cross over period is separated by a one day wash out (1 night).
• Following randomization, the participant will attend for Phase 2 visits. At Phase 2 – Visit 1(1.5hr) the randomized study lenses will be fitted by the optometrist using the study frame and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit.
• The participant will return for the Phase 2 – Visit 2(1.5hr) after a minimum of two days of bilateral spectacle wear and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit (except only one measure for Choroidal thickness and axial length measures are required). Two days are defined where the study visits are separated by two nights.
• Study Visit 2 exit; on completion of study visit 2 the Phase 0 lenses will be refitted to the study frame.
• The lens power of each product will be based on the spherical equivalent of the best-corrected subjective refraction found at baseline.
After completing all six of the Phase 2 study visits the participant will exit the clinical trial.
- The two prototype ophthalmic lens design consist of a central zone with refractive power matched to the participant’s prescription, with a peripheral zone of different refractive power. The two prototypes differ in peripheral refractive power.
-For the 2 days of bilateral spectacle wear
a) participant need to wear the spectacles for all waking hours
b) strategies for adherence included participant questionnaires that probe compliance, history taking investigating level of compliance/non-compliance at every visit.
-Phase 0 ophthalmic lenses consist of a standard single vision lens , Miyosmart myopia management lens , Stellest myopia management lens , and two prototype myopia management lens designs .
Intervention code [1] 321750 0
Treatment: Devices
Comparator / control treatment
This study has 2 control spectacle lenses which are dispensed by the research optometrist and are commercially available.
Control group
Active

Outcomes
Primary outcome [1] 329010 0
To compare the objective and subjective visual performance of participants wearing the prototype ophthalmic lenses to that observed with the commercially available lenses. The data analysis will be such that this is a composite and assessed using the Thomson visual acuity charts.
During Phase 2 Visit 1 below assessments will be done:
- Presenting visual acuity
-Slit lamp biomicroscopy
-High contrast visual acuity in high and low illumination.
-Low contrast visual acuity in high illumination
-Contrast sensitivity in high illumination
-Glare test in low illumination
-Subjective Vision Ratings:1-10 in high and low illumination -clarity of vision, ghosting, overall vision satisfaction
-Vision stability in high illumination
-Axial Length and Choroidal Thickness Measurements
Assessments for visit 2:
-Presenting VA
-Slit lamp biomicroscopy
-Subjective Vision Ratings:1-10 in high and low illumination -clarity of vision, ghosting, overall vision satisfaction
-Vision stability in high illumination
-Axial Length and Choroidal Thickness Measurements.
Timepoint [1] 329010 0
In Phase 2 after 2 days of wear
Secondary outcome [1] 401151 0
The measures will be composite. To compare the ocular physiological responses of axial length and choroidal thickness of the participants wearing the prototype ophthalmic lenses to that observed with the commercially available lenses.
Secondary outcomes relate to the impact these lenses have on physiology of the eye, specifically axial length (measured by OLCR imaging and choroidal thickness (measured by OCT imaging). These biometric markers will be measured Pre and post lens wear and will inform any potential change in either of these components
Timepoint [1] 401151 0
In Phase 2, prior to use of the ophthalmic lenses, 1 hour following use and after 2 days of use.

Eligibility
Key inclusion criteria
Age in complete years ranging from 18 to 35 years, male or female.
• Myopic spherical equivalent non-cycloplegic subjective refractive error between -0.50D to -6.50D and
cylinder up to and including -0.75DC
• Vision of 6/7.5 (20/25) or better in each eye with or without correction
• Able to read and comprehend English and give informed consent as demonstrated by signing a record
of informed consent.
• Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
• Have ocular health findings considered to be “normal”.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have strabismus and/or amblyopia.
• 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.
• 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.
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and
autoimmune 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.
• Eye surgery within 12 weeks immediately prior to enrolment for this trial.
• Previous corneal refractive surgery.
• 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/her 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)
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 2 is a single masked, dispensing and randomised design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
8/05/2021
Date of last data collection
Anticipated
Actual
11/05/2021
Sample size
Target
30
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309711 0
Other Collaborative groups
Name [1] 309711 0
Brien Holden Vision Institute
Country [1] 309711 0
Australia
Primary sponsor type
Other Collaborative groups
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] 310731 0
None
Name [1] 310731 0
Address [1] 310731 0
Country [1] 310731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309475 0
Bellberry
Ethics committee address [1] 309475 0
Ethics committee country [1] 309475 0
Australia
Date submitted for ethics approval [1] 309475 0
08/12/2020
Approval date [1] 309475 0
03/02/2021
Ethics approval number [1] 309475 0

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

Contacts
Principal investigator
Name 114270 0
Prof Padmaja Sankaridurg
Address 114270 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 114270 0
Australia
Phone 114270 0
+61407893613
Fax 114270 0
Email 114270 0
p.sankaridurg@bhvi.org
Contact person for public queries
Name 114271 0
Shinam Garg
Address 114271 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 114271 0
Australia
Phone 114271 0
+61 2 90650725
Fax 114271 0
Email 114271 0
s.garg@bhvi.org
Contact person for scientific queries
Name 114272 0
Padmaja Sankaridurg
Address 114272 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 114272 0
Australia
Phone 114272 0
+61407893613
Fax 114272 0
Email 114272 0
p.sankaridurg@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.