Clinical trial NCT05486728: Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Official title: A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: Dry Eye Disease
Lead sponsor: Dreamhawk Vision Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blinded, Parallel, Vehicle-Controlled
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

Detailed description: Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.

Eligibility criteria: 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

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

Primary outcomes:
measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle
timeFrame: Day 84
Secondary outcomes:
measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
timeFrame: Day 84
measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
timeFrame: Day 84
measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
timeFrame: Day 84
measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
timeFrame: Day 84
Other outcomes:
Locations:
city: Werribee
country: Australia
facility: Australian Eye Specialists
state: Victoria
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: Kaohsiung
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
Study officials:
References: