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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05486728




Registration number
NCT05486728
Ethics application status
Date submitted
2/08/2022
Date registered
4/08/2022

Titles & IDs
Public title
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Scientific title
A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
Secondary ID [1] 0 0
SHJ002-DED2203
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHJ002/Vehicle

Experimental: SHJ002 - SHJ002 Ophthalmic Solution will be topically administered to each eye BID for 84 days

Placebo comparator: Vehicle - Vehicle will be topically administered to each eye BID for 84 days


Treatment: Drugs: SHJ002/Vehicle
Topical ophthalmic
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle
Timepoint [1] 0 0
Day 84
Secondary outcome [1] 0 0
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Timepoint [1] 0 0
Day 84
Secondary outcome [2] 0 0
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Timepoint [2] 0 0
Day 84
Secondary outcome [3] 0 0
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Timepoint [3] 0 0
Day 84
Secondary outcome [4] 0 0
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Timepoint [4] 0 0
Day 84

Eligibility
Key inclusion criteria
1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Have DED in both eyes for = 6 months
3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ocular surface corneal disease, other than DED.
2. Lid margin disorder other than meibomian gland dysfunction (MGD)
3. Presence of any ocular condition
4. Any history of eyelid surgery or intraocular/ocular surgery
5. Cauterization of the punctum or punctal plug
6. Use of lid scrubs containing chemicals or baby shampoo, or eye makeup
7. Use of any of the contraindicated drugs medications
8. Any changes in the dosing of any chronically used systemic drug
9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
10. Known history of alcohol and/or drug abuse within 12 months
11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
12. Participation in any drug or device clinical investigation within 30 days

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2023
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Eye Specialists - Werribee
Recruitment postcode(s) [1] 0 0
3030 - Werribee
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Kaohsiung
Country [2] 0 0
Thailand
State/province [2] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dreamhawk Vision Biotech, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05486728