Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05629364




Registration number
NCT05629364
Ethics application status
Date submitted
17/11/2022
Date registered
29/11/2022
Date last updated
10/01/2024

Titles & IDs
Public title
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Scientific title
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Secondary ID [1] 0 0
KIO-101-2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KIO-101

Experimental: 0.15% KIO-101 - .15% KIO-101 eyedrops

Experimental: 0.3% KIO-101 - 0.3% KIO-101 eyedrops

Placebo Comparator: Vehicle - Vehicle eyedrops


Treatment: Drugs: KIO-101
Randomized, Controlled
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Schirmer's 1 test
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus
Erythematosus (SLE), or fibromyalgia) = 10 years

- Have an Ocular Discomfort Score (ODS) score of =3 at Screening

- Have an average VAS score = 50 at Screening; and = 40 at Baseline, Visit 2/Day 1

- Schirmer's 1 test >1 but < 10 mm at Screening.

- National Eye Institute (NEI) corneal fluorescein staining score of = 4 at Screening
(Day 14) provided that the total NEI score did not change > ± 2 grades from Screening
(Day -14) to Baseline (Day 1) visits, as confirmed by the investigator

- Have a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+1.0 LogMAR)
or better in both eyes at both the Screening and Baseline visits

- Have a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both
eyes
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have a history or presence of any ocular disorder or condition (other than dry eye
disease (DED)) in either eye that would, in the opinion of the investigator, likely
interfere with the interpretation of the study results or subject safety

- Have an autoimmune based vasculitis

- Have a history of RA > 10 years.

- Have a Schirmer's 1 test score of 0 to 1mm at Screening

- Have had a corneal transplant in either or both eyes

- Have had puncta or intracanalicular plug present in either eyelid within 1 year prior
to the Screening Visit or anticipated plug insertion or occlusion at any time during
the study

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
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2024
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Ophthalmic Trials Australia - Teneriffe
Recruitment postcode(s) [1] 0 0
4005 - Teneriffe

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kiora Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of
KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in
Patients with Autoimmune Disease
Trial website
https://clinicaltrials.gov/ct2/show/NCT05629364
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Hinds
Address 0 0
Ophthalmic Trials Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05629364