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

Study Overview
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Brief Summary
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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
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Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.

Official Title
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A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: SHJ002/Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blinded, Parallel, Vehicle-Controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHJ002<br>SHJ002 Ophthalmic Solution will be topically administered to each eye BID for 84 days | Drug: SHJ002/Vehicle<br>* Topical ophthalmic<br>|
| Placebo Comparator: Vehicle<br>Vehicle will be topically administered to each eye BID for 84 days | Drug: SHJ002/Vehicle<br>* Topical ophthalmic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle | change from Baseline in corneal fluorescein staining (CFS) at Final Visit | Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 84 | 
| 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) | Day 84 | 
| 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). | Day 84 | 
| 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) | Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Disease