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Trial registered on ANZCTR


Registration number
ACTRN12622000935730
Ethics application status
Approved
Date submitted
22/06/2022
Date registered
30/06/2022
Date last updated
12/06/2024
Date data sharing statement initially provided
30/06/2022
Date results information initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of the clock time and light on myopia control contact lens wear
Scientific title
Influence of the time-of-day factor on short-term ocular response to light and myopia control lenses in myopic adults
Secondary ID [1] 307389 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 326699 0
Condition category
Condition code
Eye 323946 323946 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be six one-hour visits in total, where three visits scheduled in the morning and three in the afternoon on different days. During each visit, participants will be wearing commercially available multi-focal contact lenses individualized based on their presenting prescription, simultaneously with goggles (commercial welding goggles) fitted with one type of the light filters (in random order): neutral density filters, red filters and blue filters. Same contact lenses will be provided across all visits. Audiobooks will be played at the background for participants' entertainment while they are sitting still in a chair during this one hour period.
Participants will attend the two control visits (with neutral density filters, morning and afternoon) first, followed by the other four visits (with blue or red filters) in a random order. Wash out period between the four visits will be at least 24 hours (no wash out for the neutral density filters conditions as they are considered as placebo).
The researcher will be monitoring participant's adherence to the intervention via verbal confirmation during and at the end of study.
Intervention code [1] 323851 0
Treatment: Devices
Comparator / control treatment
Goggles with the neutral density filters will be used for the control condition.
Control group
Placebo

Outcomes
Primary outcome [1] 331780 0
Axial length changes of the eye measured using non-contact ocular biometry instrument ( LenStar; Haag-Streit, Switzerland).
Timepoint [1] 331780 0
Pre- and post-intervention at each visit (visit 1 to visit 6).
Secondary outcome [1] 411103 0
Changes in the choroidal thickness of the eye measured by non-contact Optical Coherence Tomography (OCT) imaging.
Timepoint [1] 411103 0
Pre- and post-intervention at each visit (visit 1 to visit 6).

Eligibility
Key inclusion criteria
1. Adults with good general health, age range 18 to 35 years
2. Best-corrected visual acuity of 20/20 or better in each eye, short-sighted (myopic spherical equivalent between 0.5D and 5D)
3. Experienced contact lens wearers
4. Have ocular health findings considered to be ‘normal’ (E.g. no ocular diseases, colour vision deficiency or history of eye surgery)
5. Willing to sign informed consent and comply with study schedule
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Systemic diseases that may affect ocular health (e.g. hypertension, diabetes mellitus, etc.)
2. Ocular disease or history of eye surgery
3. Use of myopia control medications or devices
4. Use of melatonin or any pharmacological sleep aids
5. Use of or a need for any medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology either in an adverse or beneficial manner
6. Travelled between different time zones within two months upon participating in the study
7. Current smoker

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The estimated sample size for the project is between 16 to 20. This sample size is sufficient to meet the research aims and answer the research questions because this study does not intend to generalise to broader populations, but to gain an in-depth understanding of the topic. Research studies examining similar topics with sample sizes ranging from 15 to 20 participants have allowed the researchers to reach saturation of themes during data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2022
Actual
12/07/2022
Date of last participant enrolment
Anticipated
3/10/2022
Actual
2/12/2022
Date of last data collection
Anticipated
28/10/2022
Actual
14/03/2023
Sample size
Target
16
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37862 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 311666 0
Other Collaborative groups
Name [1] 311666 0
Brien Holden Vision Institute Limited
Country [1] 311666 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute Limited
Address
Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 313148 0
None
Name [1] 313148 0
Address [1] 313148 0
Country [1] 313148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311122 0
UNSW HREC Executive
Ethics committee address [1] 311122 0
Level 3, Rupert Myers Building (South Wing), Gate 14, Barker Street UNSW, Sydney, NSW 2052.
Ethics committee country [1] 311122 0
Australia
Date submitted for ethics approval [1] 311122 0
08/09/2021
Approval date [1] 311122 0
29/10/2021
Ethics approval number [1] 311122 0
HC210744

Summary
Brief summary
The research study aims to explore the potential interaction between application time of the day and short-term myopia (or ‘short-sightedness’) control contact lens wear and different lighting conditions.
Participants will wear contact lenses and goggles fitted with one of the three different light filters (neutral density filters, blue filters and red filters) during each visit and their eyes will be measured using non-invasive methods at the beginning and the end of each visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120014 0
Prof Padmaja Sankaridurg
Address 120014 0
Brien Holden Vision Institute Limited
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street UNSW SYDNEY NSW 2052
Country 120014 0
Australia
Phone 120014 0
+61407893613
Fax 120014 0
Email 120014 0
p.sankaridurg@bhvi.org
Contact person for public queries
Name 120015 0
Prof Padmaja Sankaridurg
Address 120015 0
Brien Holden Vision Institute Limited
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street UNSW SYDNEY NSW 2052
Country 120015 0
Australia
Phone 120015 0
+612 90650700
Fax 120015 0
Email 120015 0
p.sankaridurg@bhvi.org
Contact person for scientific queries
Name 120016 0
Prof Padmaja Sankaridurg
Address 120016 0
Brien Holden Vision Institute Limited
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street UNSW SYDNEY NSW 2052
Country 120016 0
Australia
Phone 120016 0
+612 90650700
Fax 120016 0
Email 120016 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
To protect the identity of the participant.


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.