Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2025-04-17

Brief Summary

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The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.

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 twice daily for 12 weeks.

Conditions

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Corneal Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blinded, Parallel, Vehicle-Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-Blinded, Parallel, Vehicle-Controlled

Study Groups

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SHJ002

SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks

Group Type EXPERIMENTAL

SHJ002

Intervention Type DRUG

Topical ophthalmic

Vehicle

Vehicle: topically administered to each eye twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Topical ophthalmic

Interventions

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SHJ002

Topical ophthalmic

Intervention Type DRUG

Vehicle

Topical ophthalmic

Intervention Type OTHER

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. Diagnosis with Sjogren's syndrome and have corneal erosion
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 corneal erosion and dry eye disease (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 eyelid 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