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Trial registered on ANZCTR


Registration number
ACTRN12621001425886
Ethics application status
Approved
Date submitted
5/02/2021
Date registered
21/10/2021
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare prototype ophthalmic lenses and commercially available ophthalmic lenses -Part 1 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 1 of 2).
Secondary ID [1] 303004 0
CRTC2019-06
Universal Trial Number (UTN)
Trial acronym
The Calvin Study
Linked study record
ACTRN12621001399886

Health condition
Health condition(s) or problem(s) studied:
Myopia 320060 0
Condition category
Condition code
Eye 317989 317989 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study consist of two phases;
Phase 0: The participant will attend a single Phase 0 visit where the pre-ordered single vision lenses will be fitted into the study spectacle frame and assessments will be performed.The study questionnaires will be completed 1 hour following dispensing of the Phase 0 spectacles.
The purpose of Phase 0 is to ensure all study participants have:
• A preselected spectacle frame to allow trial lenses to be fitted immediately into that frame at the start of each trial cycle.
• Adapted to the standard spectacles lenses which have the same base curve, lens material and anti-reflection coating as the prototype study lenses. The participant will be dispensed the single vision lenses and required to wear for at least a single day prior to attending initial Phase 1 or 2 visits.

Phase 1: At Phase 1 (Non dispensing phase); minimum of 3 to up to 10
visits- 1 visit per lens type.
-Each study visit (1.5 hours); non-dispensing lens wearing period of a minimum of 1 hour Study Visit 1 the study lenses will be fitted into the study frame and the assessments will be performed by the study optometrist. The study lens order will be non-randomised..
• Participants may trial multiple study lenses in Phase 1 with a minimum of 60-minute washout period between lens design assessments.
-Each participant may evaluate up to two study lens designs on a single day.
-The number of lenses participants receive will be primarily determined by participant availability, so long as protocol criteria is met (i.e. each participant must test at least one control and one test lens, and, each test lens must be tested by 10 different participants).
-The distinguishing features of the four test lenses relate to the magnitude, rate, and distribution profile of the peripheral power progression. All four lenses differ in this regard.
Intervention code [1] 319291 0
Treatment: Devices
Comparator / control treatment
This study has 2 controls that are spectacle lenses which are dispensed by the research optometrist.
The control lenses are commercially available myopia spectacle lenses.
Control 1: Miyosmart manufactured by Hoya, Japan
Control 2: Stellest manufactured by Essilor, France
-The test lenses have a similar central optical design to correct the refractive error and the peripheral optical design differs in refractive power to the controls.
-Each participant will be provided with one passive control lens (single vision) and at least one active control lenses.
-Participants are expected to wear the passive control lens (single vision) for all waking hours, as a replacement of their habitual spectacles unless they are wearing a test lens in phase 1 or 2 (active control or prototype lens), in which case they will be directed on phase-specific wearing schedules.
- Strategies included participant questionnaires that probe compliance, history taking investigating level of compliance/non-compliance at every visit.
Control group
Active

Outcomes
Primary outcome [1] 325993 0
Phase 1: 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 the study visit the assessment process will be:
o Choroidal thickness and axial length measures
o Wearing of the allocated study lens
o Vision assessment
o A break period (to ensure a minimum of 60 mins between Choroidal thickness measures)
o Study questionnaires
o Choroidal thickness and axial length measures
o Complete study visit
2. Method of assessment of
a. Choroidal thickness: OCT imaging; Axial length: OLCR imaging
b. Vision assessment:
i. Objective measures: Visual Acuity (LogMAR), Contrast sensitivity (Pelli-Robson),
ii. Subjective measures: Vision Gradings (with reference scale provided), Participant Questionnaire, Dynamic Head Movement Test
3. Study-specific questionnaire
Timepoint [1] 325993 0
In Phase 1 after 1 hour of wear
Secondary outcome [1] 389792 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.
- Choroidal thickness: OCT imaging (Swept Source);
- Axial length: OLCR imaging
Timepoint [1] 389792 0
In Phase 1, prior to use of the ophthalmic lenses and 1 hour following 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
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
Parallel
Other design features
Phase 0 is a single masked, dispensing and non randomised design.
Phase 1 is a single masked, non dispensing and non randomised design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2021
Date of last participant enrolment
Anticipated
Actual
12/03/2021
Date of last data collection
Anticipated
Actual
14/04/2021
Sample size
Target
30
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307412 0
Other Collaborative groups
Name [1] 307412 0
Brien Holden Vision Institute
Country [1] 307412 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] 308080 0
None
Name [1] 308080 0
Address [1] 308080 0
Country [1] 308080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307497 0
Bellberry
Ethics committee address [1] 307497 0
Ethics committee country [1] 307497 0
Australia
Date submitted for ethics approval [1] 307497 0
08/12/2020
Approval date [1] 307497 0
03/02/2021
Ethics approval number [1] 307497 0

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

Contacts
Principal investigator
Name 107446 0
Prof Padmaja Sankaridurg
Address 107446 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 107446 0
Australia
Phone 107446 0
+61407893613
Fax 107446 0
Email 107446 0
p.sankaridurg@bhvi.org
Contact person for public queries
Name 107447 0
Shinam Garg
Address 107447 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 107447 0
Australia
Phone 107447 0
+61 2 90650725
Fax 107447 0
Email 107447 0
s.garg@bhvi.org
Contact person for scientific queries
Name 107448 0
Padmaja Sankaridurg
Address 107448 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 107448 0
Australia
Phone 107448 0
+61407893613
Fax 107448 0
Email 107448 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.