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Trial registered on ANZCTR


Registration number
ACTRN12623001230640
Ethics application status
Approved
Date submitted
11/10/2023
Date registered
30/11/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
30/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease
Scientific title
A Multicenter, Randomized, Controlled, Double-Masked, Phase 2 Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease
Secondary ID [1] 309975 0
ILYX-002-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry-Eye Disease 330461 0
Condition category
Condition code
Eye 327314 327314 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is designed to evaluate the safety and tolerability and explore the potential therapeutic effects of repeat dosing of ILYX-002 compared to vehicle control in participants with dry-eye disease (DED) with autoimmune disease.

This trial will include a sentinel cohort of 2 participants. The sentinel cohort will be conducted at a single-site as a single-masked, non-controlled, staggered-dosing design to evaluate the safety of low-dose (0.1%) and high-dose (0.3%) ILYX-002 administered as 1 drop in each eye twice daily through to Day 85. The first dose and each subsequent in-clinic dose will be administered under direct supervision at the study site and ongoing compliance with administration will be assessed by review of bottle returns at each visit. The dosing of sentinel participants will be staggered, with the safety profile of the initial sentinel participant gating the commencement of the second sentinel participant. Safety evaluation of each treatment arm at a minimum of 7 days of dosing will gate initiation of the Phase 2 trial.

In the Phase 2 trial, participants will be randomised to 1 of the following 2 treatment groups in a 1:1 ratio as follows:
Group 1: ILYX-002 0.3% (1 drop into each eye twice daily through to Day 57)
Group 2: Vehicle (1 drop into each eye twice daily through to Day 57)
The first dose and each subsequent in-clinic dose will be administered under direct supervision at the study site and the participant will continue twice-daily dosing at home until the next visit. Ongoing compliance with administration will be assessed by review of bottle returns at each visit.
After Day 57, participants will continue to be monitored for safety until Day 71.
Intervention code [1] 326385 0
Treatment: Drugs
Comparator / control treatment
Group 2 of the study will serve as the control arm. Participants in group 2 will receive vehicle, which is the same composition as ILYX-002 but without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 335177 0
To assess the safety and tolerability of ILYX-002 administered twice daily compared to vehicle. Safety and tolerability will be assessed by ocular and non-ocular adverse events elicited by spontaneous reporting by the participant or non-leading inquiry, intraocular pressure assessed by tonometry, best corrected visual acuity measured by visual assessment with Snellen chart, external eye examination via slit-lamp biomicroscopy, assessment of the retina via dilated ophthalmoscopy and ocular tolerability as reported by participants in questionnaires.
Timepoint [1] 335177 0
Adverse event data will be collected until day 71 post-commencement of eye drops. Slit-lamp biomicroscopy/external eye examination, best corrected visual acuity and tonometry assessments will be completed on days -14, 1, 15, 29, 57 and 71 post-commencement of eye drops. Ocular tolerability assessments will be completed on days -14, 1, 15, 29, 57 and 71 post-commencement of eye drops. Dilated ophthalmoscopy will be completed on days -14, 1 and 57 post-commencement of eye drops.
Primary outcome [2] 335178 0
To assess the therapeutic effect of ILYX-002 administered twice daily compared to vehicle, in terms of the total lissamine green conjunctival staining (tLGCS) score. The therapeutic endpoint is the change from baseline to Week 8 in the total lissamine green conjunctival staining (tLGCS) score, in the trial eye, graded according to the National Eye Institute (NEI) 0-3 grading scale.
Timepoint [2] 335178 0
The therapeutic endpoint will be assessed at days -14, 1, 15, 29, 57 post-commencement of eye drops.
Secondary outcome [1] 423395 0
To assess the therapeutic effect of ILYX-002 administered twice daily compared to vehicle in the treatment of Dry-Eye Disease, in terms of the total corneal fluorescein staining (tCFS) score. The therapeutic endpoint is the change from baseline to Week 8 in the total cornel fluorescein staining (tCFS) score, graded according to the Lexitas modified NEI 0-4 grading scale.
Timepoint [1] 423395 0
The therapeutic endpoint will be assessed at days -14, 1, 15, 29, 57 post-commencement of eye drops.

Eligibility
Key inclusion criteria
1. Male or Female >=18 and <=85 years
2. History of autoimmune disease
3. BCVA of 20/100 or better in trial eye
4. Moderate to severe Dry Eye Disease
5.. Use of artificial tears at least 2 times per days for at least 30 days prior to screening
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity or contraindications to the trial treatment or its components
2. Within 30 days prior to screening have taken contraindicated medications or investigational treatments
3. Contact lens use during the trial
4. Ocular surface or anterior segment surgery within 12 months of screening
5. Change in dose or frequency within 90 days prior to screening, or anticipated during trial, of chronic medications
6. History of uncontrolled glaucoma or actively being treated for glaucoma
7. History of punctal cautery
8. Current use of punctal plugs
9. Hepatic insufficiency
10. Currently pregnant or lactating.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central blocked randomisation will be used. Sequence generation will be done by the independent statistician using a secure web-based randomisation system.
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
Other
Other design features
This trial will include a sentinel cohort of 2 participants. The sentinel cohort will be
conducted at a single-site as a single-masked, non-controlled, staggered-dosing design to
evaluate the safety of low- (0.1%) and high-dose (0.3%) ILYX-002.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 25342 0
Mark Hinds Optometrists - Teneriffe
Recruitment hospital [2] 25343 0
Westmead Hospital - Westmead
Recruitment hospital [3] 25344 0
School of Optometry and Vision Science - Kensington
Recruitment hospital [4] 25365 0
The University of Melbourne, Department of Optometry and Vision Science - Carlton
Recruitment hospital [5] 25367 0
University of the Sunshine Coast Clinical Trials Centre - Birtinya - Birtinya
Recruitment hospital [6] 25684 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 41509 0
2000 - Sydney
Recruitment postcode(s) [2] 41051 0
2033 - Kensington
Recruitment postcode(s) [3] 41050 0
2145 - Westmead
Recruitment postcode(s) [4] 41094 0
3053 - Carlton
Recruitment postcode(s) [5] 41049 0
4005 - Teneriffe
Recruitment postcode(s) [6] 41096 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 314149 0
Commercial sector/Industry
Name [1] 314149 0
Iolyx Australia Pty Ltd.
Country [1] 314149 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Iolyx Australia Pty Ltd.
Address
Level 17, 'HWT Tower', 40 City Road, Southbank VIC 3006
Country
Australia
Secondary sponsor category [1] 316068 0
None
Name [1] 316068 0
None
Address [1] 316068 0
None
Country [1] 316068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313284 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313284 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 313284 0
Australia
Date submitted for ethics approval [1] 313284 0
09/08/2023
Approval date [1] 313284 0
03/10/2023
Ethics approval number [1] 313284 0
Ethics committee name [2] 313498 0
The University of Melbourne Central Human Research Ethics Committee
Ethics committee address [2] 313498 0
University of Melbourne Parkville 3010 VIC
Ethics committee country [2] 313498 0
Australia
Date submitted for ethics approval [2] 313498 0
09/08/2023
Approval date [2] 313498 0
24/10/2023
Ethics approval number [2] 313498 0

Summary
Brief summary
The purpose of this study is to assess the safety and therapeutic effects (how well a treatment works) of ILYX-002 for the treatment of Dry-Eye Disease. This study will be conducted in patients with Autoimmune Disease, aged 18-85 years old.

This study will compare ILYX-002 with vehicle/placebo. A vehicle is a medication with no active ingredients. It looks similar to the real thing, but it is not. One group of participants will receive ILYX-002 and the other group will receive the vehicle/placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive vehicle/placebo. Each group will involve approximately 55 participants, with 110 participants to be enrolled in total.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127598 0
Prof Mark Hinds
Address 127598 0
Ophthalmic Trials Australia, Suite 2/53 Commercial Rd, Teneriffe QLD 4055
Country 127598 0
Australia
Phone 127598 0
+61 7 36082074
Fax 127598 0
Email 127598 0
mark@markhindsoptometrists.com.au
Contact person for public queries
Name 127599 0
Prof Mark Hinds
Address 127599 0
Ophthalmic Trials Australia, Suite 2/53 Commercial Rd, Teneriffe QLD 4055
Country 127599 0
Australia
Phone 127599 0
+61 7 36082074
Fax 127599 0
Email 127599 0
mark@markhindsoptometrists.com.au
Contact person for scientific queries
Name 127600 0
Dr Greg Plunkett
Address 127600 0
Accelagen Pty Ltd, Suite 2.02/785 Toorak Rd, Hawthorn East VIC 3123
Country 127600 0
Australia
Phone 127600 0
+61 3 91142274
Fax 127600 0
Email 127600 0
greg.plunkett@accelagen.com.au

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.