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Trial registered on ANZCTR


Registration number
ACTRN12624000317594
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
25/03/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes to tear pro-inflammatory proteins (cytokines) in new contact lens wearers.
Scientific title
Changes to tear pro-inflammatory proteins (cytokines) in new contact lens wearers.
Secondary ID [1] 311389 0
CV-22-26
Universal Trial Number (UTN)
U1111-1303-1592
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort
 332663 0
Condition category
Condition code
Eye 329367 329367 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention will be CooperVision Clariti 1 Day and Clariti 1 Day Toric contact lenses (CLs), which provide improved visual clarity by correcting the refractive error of the eyes. The CooperVision Clariti 1 Day CLs, corrects the refractive errors, nearsightedness (myopia) and farsightedness (hyperopia), while the CooperVision Clariti 1 Day Toric CLs, additionally corrects refractive errors associated with astigmatism. Participants with nearsightedness or farsightedness and astigmatism less than -0.75DC will be fitted with CooperVision Clariti 1 day CLs. Participants with nearsightedness or farsightedness and astigmatism equal or greater than -0.75 DC will be fitted with Clariti 1 Day toric CLs. Both lenses are commercially available daily disposable silicone-hydrogel CLs, to be worn by participants on a daily wear only basis, at least four times per week (at least eight hours per day) over a six month period. Participants recruited for this study will be naïve to CL wear (i.e., have not worn CLs before), who are interested in wearing CLs for the first time.

The study researchers, who are qualified optometrists, will teach eligible participants how to apply and remove the CLs, before being provided with contact lenses to use independently. The participants will have to demonstrate their ability to perform these techniques safely on their own. Eligible participants will be provided with approximately 180 pairs of Clariti 1 Day and Clariti 1 Day Toric CLs, including a suitable number of spare pairs, over the study duration. Participants will be required to return all unused contact lenses at each follow-up visit to monitor contact lens wear compliance.

This study will evaluate the relationship between tear proteins and eye comfort during soft CL wear. The primary aim will be to determine whether certain tear proteins are predictive of individuals who develop discomfort with CLs at the end of their daily wear period. At the conclusion of the study, participants will be 'grouped' in to symptomatic (those participants who experience discomfort) and asymptomatic (those who do not experience discomfort) CLs wearers, based upon CLs wear time and responses to subjective questionnaires. Further inter-group comparisons will be made between these two groups.
Intervention code [1] 327830 0
Treatment: Devices
Comparator / control treatment
There will be no control groups in this research study. However, at the conclusion of the study, participants will be 'grouped' in to symptomatic (those participants who experience discomfort) and asymptomatic (those who do not experience discomfort) CLs wearers, based upon CLs wear time and responses to subjective questionnaires. Further inter-group comparisons will be made between these two groups.
Control group
Active

Outcomes
Primary outcome [1] 337186 0
Levels of pro-inflammatory proteins in tear samples of symptomatic and asymptomatic contact lens wearers.
Timepoint [1] 337186 0
Visit 1 (baseline), Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
Primary outcome [2] 337195 0
Optimal threshold levels of tear pro-inflammatory proteins to predict symptomatic contact lens wear.
Timepoint [2] 337195 0
Visit 1 (baseline), Visit 2 (day 1), Visit 3 (day 7), Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
Secondary outcome [1] 431023 0
Subjective, end of day ocular symptoms.
Timepoint [1] 431023 0
Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
Secondary outcome [2] 431024 0
Severity of Ocular surface signs
Timepoint [2] 431024 0
Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
Secondary outcome [3] 431025 0
Subjective contact lens performance
Timepoint [3] 431025 0
Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
Secondary outcome [4] 431026 0
Difference in density of corneal T cells between asymptomatic and symptomatic contact lens wearers.
Timepoint [4] 431026 0
Visit 1 (baseline) to Visit 6 (Day 180)
Secondary outcome [5] 432666 0
Difference in density of corneal dendritic cells between asymptomatic and symptomatic contact lens wearers.
Timepoint [5] 432666 0
Visit 1 (baseline) and Visit 6 (Day 180)
Secondary outcome [6] 432667 0
Difference in morphology of corneal T cells between asymptomatic and symptomatic contact lens wearers.
Timepoint [6] 432667 0
Visit 1 (baseline) and Visit 6 (Day 180)
Secondary outcome [7] 432672 0
Difference in morphology of corneal dendritic cells between asymptomatic and symptomatic contact lens wearers.
Timepoint [7] 432672 0
Visit 1 (baseline) to Visit 6 (Day 180)

Eligibility
Key inclusion criteria
1. Male or female, aged 18-45 years of age;
2. Provide written informed consent and documentation, in accordance with privacy requirements, obtained prior to performing any study procedures;
3. Ability to understand and follow study instruction, with the intention of completing all of the required study visits;
4. In good general health;
5. Have never worn CLs;
6. Have a CL spherical prescription range of -0.50 to -6.00 D and +0.50 to +4.00 D and a CL cylindrical prescription range of up to -2.25 DC.
7. An acceptable soft CL fit and vision in both eyes with Clariti 1 Day contact lenses (sphere or toric), per the judgement of the study investigator;
8. Demonstrated capacity for independent, competent and safe CL application and removal at Visit 2, per the judgement of the study investigator;
9. Be motivated and willing to wear CLs for a minimum of four days per week, eight hours per day, over the study duration;
10. Best-corrected visual acuity with CL correction of at least 6/9 (20/30) in each eye;
11. Not regularly (once per day only) using artificial tear eye drops in the month prior to enrolment, or planned over the course of the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have any known active ocular disease and/or infection (including DED);
2. Presence of any of the following conditions: active ocular inflammation, active ocular allergy, a corneal disorder or abnormality that could affect corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment investigator may interfere with the interpretation of the study results;
3. Have any ocular injury to either eye in the 12 weeks prior to Visit 1;
4. Have undergone any ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned over the course of their participation in the study;
5. Any prior history of laser refractive eye surgery;
6. Have a known allergy to, or previous reaction to, any eye drops required for the study;
7. Presence of significant corneal scarring or a physical factor that impairs the ability to perform corneal imaging;
8. Clinically significant dry eye disease, as specified in the TFOS DEWS II definition, defined by dry eye symptoms (i.e., an Ocular Surface Disease Index (OSDI) score greater than or equal to 13, out of 100 (Schiffman et al., 2000)) and one or more of the following clinical signs (Wolffsohn et al., 2017):
a. Tear osmolarity of greater than or equal to 308 mOsm/L in either eye or interocular differences greater than 8mOsm/L;
b. TBUT less than 10 sec in either eye;
c. Ocular surface staining: greater than 5 corneal spots, greater than 9 conjunctival spots, or lid margin (greater than or equal to 2 mm length and greater than or equal to 25% width)
9. Current use of any topical medications other than artificial lubricant eye drops;
10. Women who are pregnant or breastfeeding at the time of study entry or who plan to become pregnant during the study (as reported by the participant);
11. Any vaccination within 1 week of Visit 1, by self-report;
12. Any upper respiratory viral infection within 2 weeks of Visit 1, by self-report;
13. Inability to sit/lie supine comfortably during the examination procedures;
14. Participation in an interventional clinical trial within the previous 30 days, or currently enrolled in an interventional clinical trial;
15. Current use of any eye drop or other therapy, or history of an intervention, that may make CL wear risky or challenging (e.g., use of glaucoma eye drop medications, filtering bleb, etc.);
16. A condition or situation that, in the opinion of the study investigator, will limit the potential participant’s ability to comply with the study protocol or might adversely affect their safety.

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size: As this is an exploratory, proof-of-concept study, it is not possible to calculate a sample size using conventional statistical methods (which require a reliable estimate of effect size and variability). The nominated sample size of 50 participants is based on the rationale that this number of population samples will achieve the reasonable expectations for an analysis based upon the normal distribution (z-test) to be valid. Recruitment feasibility is also supported by this estimate.

Continuous variables will be summarized using the number of observations, mean, standard deviation (SD), median, minimum, and maximum, as well as confidence intervals or confidence limits, as applicable. Categorical variables will be summarized with frequencies and percentages from each category. Quantitative analyses of collected data will be undertaken using robust statistical methods, as appropriate for the data, to assess for differences between the study groups (i.e., asymptomatic and symptomatic CL wearers) over the study duration (e.g., a repeated measures ANOVA or equivalent). Correlation analyses will be performed to assess for potential relationships between clinical parameters and tear cytokine profiles (e.g., correlation between CL comfort and the concentration of a particular tear protein).

Specifically, the following relationships will be investigated for the primary analysis:
- The inter-group (asymptomatic vs symptomatic CL wearers) difference in pro-inflammatory tear proteins at Visit 1 (baseline)
- The optimal threshold levels of baseline pro-inflammatory tear proteins, that are predictive of CL discomfort at visit 6 (day 180).

The secondary analysis will focus upon:
- Inter-group difference for the change from baseline, in tear pro-inflammatory proteins at Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
- The optimal threshold levels of pro-inflammatory tear proteins at Visit 1 (baseline), Visit 2 (day 1), Visit 3 (day 7), Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180), that are predictive of CL discomfort at study end.
- Correlation between baseline levels of tear pro-inflammatory proteins and end of day (PM) Symptom Index – VAS scored at Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
- Correlation between baseline levels of tear pro-inflammatory proteins and ocular surface signs at Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
- Correlation between tear pro-inflammatory tear proteins and CLDEQ-8 scores at Visit 4 (day 30), Visit 5 (day 90) and Visit 6 (day 180).
- Inter-group difference for corneal immune cell features at Visit 1 (baseline) and at Visit 6 (Day 180).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2024
Actual
19/04/2024
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
50
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26074 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 41929 0
3010 - Parkville

Funding & Sponsors
Funding source category [1] 315648 0
Commercial sector/Industry
Name [1] 315648 0
CooperVision International Limited
Country [1] 315648 0
United States of America
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 317750 0
None
Name [1] 317750 0
Address [1] 317750 0
Country [1] 317750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314533 0
Office of Research Ethics and Integrity (OREI), University of Melbourne
Ethics committee address [1] 314533 0
Ethics committee country [1] 314533 0
Australia
Date submitted for ethics approval [1] 314533 0
15/01/2024
Approval date [1] 314533 0
12/02/2024
Ethics approval number [1] 314533 0
2024-28446-49246-2

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

Contacts
Principal investigator
Name 131918 0
Prof Laura Downie
Address 131918 0
Department of Optometry and Vision Sciences University of Melbourne 200 Berkeley Street, Carlton VIC 3053
Country 131918 0
Australia
Phone 131918 0
+61 3 9035 3043
Fax 131918 0
Email 131918 0
ldownie@unimelb.edu.au
Contact person for public queries
Name 131919 0
Laura Downie
Address 131919 0
Department of Optometry and Vision Sciences University of Melbourne 200 Berkeley Street, Carlton VIC 3053
Country 131919 0
Australia
Phone 131919 0
+61 3 9035 3043
Fax 131919 0
Email 131919 0
ldownie@unimelb.edu.au
Contact person for scientific queries
Name 131920 0
Laura Downie
Address 131920 0
Department of Optometry and Vision Sciences University of Melbourne 200 Berkeley Street, Carlton VIC 3053
Country 131920 0
Australia
Phone 131920 0
+61 3 9035 3043
Fax 131920 0
Email 131920 0
ldownie@unimelb.edu.au

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


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.