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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2023-12-07

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.

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blinded, Parallel, Vehicle-Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SHJ002

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

Group Type EXPERIMENTAL

SHJ002/Vehicle

Intervention Type DRUG

Topical ophthalmic

Vehicle

Vehicle: topically administered to each eye BID for 84 days

Group Type PLACEBO_COMPARATOR

SHJ002/Vehicle

Intervention Type DRUG

Topical ophthalmic

Interventions

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SHJ002/Vehicle

Topical ophthalmic

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No