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Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SHJ002/Vehicle
Sponsored by
Dreamhawk Vision Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Australian Eye SpecialistsRecruiting
  • Kaohsiung Veterans General HospitalRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • Ramathibodi Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHJ002

Vehicle

Arm Description

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

Vehicle will be topically administered to each eye BID for 84 days

Outcomes

Primary Outcome Measures

To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle
change from Baseline in corneal fluorescein staining (CFS) at Final Visit

Secondary Outcome Measures

To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Symptom Assessment in Dry Eye (SANDE) The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Conjunctival hyperemia The reference scale consists of 6 levels or grades of conjunctival hyperemia (0 = none, 5 = severe)
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Eye dryness / Visual Analogue Scale (VAS) 100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort).
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Non-invasive tear break up time (NIBUT)

Full Information

First Posted
August 2, 2022
Last Updated
October 17, 2023
Sponsor
Dreamhawk Vision Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05486728
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dreamhawk Vision Biotech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-Blinded, Parallel, Vehicle-Controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHJ002
Arm Type
Experimental
Arm Description
SHJ002 Ophthalmic Solution will be topically administered to each eye BID for 84 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle will be topically administered to each eye BID for 84 days
Intervention Type
Drug
Intervention Name(s)
SHJ002/Vehicle
Intervention Description
Topical ophthalmic
Primary Outcome Measure Information:
Title
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle
Description
change from Baseline in corneal fluorescein staining (CFS) at Final Visit
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Description
Symptom Assessment in Dry Eye (SANDE) The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms
Time Frame
Day 84
Title
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Description
Conjunctival hyperemia The reference scale consists of 6 levels or grades of conjunctival hyperemia (0 = none, 5 = severe)
Time Frame
Day 84
Title
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Description
Eye dryness / Visual Analogue Scale (VAS) 100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort).
Time Frame
Day 84
Title
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED
Description
Non-invasive tear break up time (NIBUT)
Time Frame
Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent. Have DED in both eyes for ≥ 6 months Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test Exclusion Criteria: Ocular surface corneal disease, other than DED. Lid margin disorder other than meibomian gland dysfunction (MGD) Presence of any ocular condition Any history of eyelid surgery or intraocular/ocular surgery Cauterization of the punctum or punctal plug Use of lid scrubs containing chemicals or baby shampoo, or eye makeup Use of any of the contraindicated drugs medications Any changes in the dosing of any chronically used systemic drug Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol Known history of alcohol and/or drug abuse within 12 months Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents. Participation in any drug or device clinical investigation within 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suh-Hang H. Juo, MD, Ph.D.
Phone
+886-975357586
Email
hjuo@shvbiotech.com
Facility Information:
Facility Name
Australian Eye Specialists
City
Werribee
State/Province
Victoria
ZIP/Postal Code
3030
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandor Jaross
Phone
+61 1300 150 806
First Name & Middle Initial & Last Name & Degree
Nandor Jaross
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
813414
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiunn-Liang Chen, MD
Phone
886-7342-2121
Email
eyegogo@gmail.com
First Name & Middle Initial & Last Name & Degree
Jiunn-Liang Chen, MD
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngamjit Kasetsuwan
Phone
081-920-0553
Email
ngamjitk@gmail.com
First Name & Middle Initial & Last Name & Degree
Ngamjit Kasetsuwan
First Name & Middle Initial & Last Name & Degree
Usanee Reinprayoon
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

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