- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104388
Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study of SJP-0035 Ophthalmic Solution Compared With Placebo to Assess Safety and Efficacy of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is currently no product approved for corneal epithelial wound healing. A Phase 1 Study SJP-0035/1-01 was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders.
This Phase 2a study is being conducted to evaluate the safety and efficacy of SJP-0035 ophthalmic solution in patients to promote corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Senju Investigational Site
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California
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Glendale, California, United States, 91206
- Senju Investigational Site
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Glendora, California, United States, 91741
- Senju Investigational Site
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Huntington Beach, California, United States, 92647
- Senju Investigational Site
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Lancaster, California, United States, 93534
- Senju Investigational Site
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Newport Beach, California, United States, 92663
- Senju Investigational Site
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Pasadena, California, United States, 91107
- Senju Investigational Site
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Petaluma, California, United States, 94954
- Senju Investigational Site
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Santa Maria, California, United States, 93454
- Senju Investigational Site
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Illinois
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Hoffman Estates, Illinois, United States, 60169
- Senju Investigational Site
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Kentucky
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Edgewood, Kentucky, United States, 41017
- Senju Investigational Site
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Missouri
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Kansas City, Missouri, United States, 64111
- Senju Investigational Site
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New Jersey
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Palisades Park, New Jersey, United States, 07650
- Senju Investigational Site
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New York
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Rochester, New York, United States, 14642
- Senju Investiational Site
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North Carolina
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High Point, North Carolina, United States, 27262
- Senju Investigational Site
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Senju Investigational Site
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Virginia
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Norfolk, Virginia, United States, 23502
- Senju Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female between the ages of 18 and 75 years, inclusive.
- Has moderate to severe superficial punctate keratitis (SPK) and/or corneal erosion in 1 or both eyes.
- Has symptoms caused by corneal epithelial disorders.
- Has not obtained improvement from previous treatment for the SPK or corneal erosion within the last 30 days.
- Is a female of childbearing potential with a negative pregnancy test result at Screening and baseline and agrees to use effective contraception throughout the study or is a postmenopausal woman with a negative pregnancy test result at Screening and baseline.
Exclusion Criteria:
- Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, or chemical burns or any trauma to the cornea.
- Any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures.
- Had previous ocular/refractive surgery (including laser surgery) within the last 6 months.
- Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) within 14 days prior to the first dose of study drug, or who are anticipated to require such medications during the study. Artificial tears may be used up to 72 hours prior to the first dose.
- Is unable to discontinue Restasis. A 28-day washout period prior to the first dose of study drug is required.
- Is a contact lens wearer and cannot discontinue use for the duration of the study.
- Alcohol or drug abuse within the past 6 months.
- Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus test at Screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SJP-0035 Ophthalmic Solution
Patients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
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Placebo Comparator: Vehicle of SJP-0035 Ophthalmic Solution
Patients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearing of corneal fluorescein staining at week 4
Time Frame: measured at Week 4
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A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared.
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measured at Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety.
Time Frame: baseline up to week 18
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An Adverse Event is defined as any untoward medical occurrence in a patient enrolled into the study regardless of its causal relationship to study drug.
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baseline up to week 18
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Changes of subjective symptoms: blurred vision, photophobia and eye irritation
Time Frame: screening up to week 18
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100-point assessments are performed for the symptom of blurred vision, photophobia and eye irritation.
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screening up to week 18
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Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea
Time Frame: screening up to week 18
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These changes are measured at every study visit using standard ophthalmology procedures.
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screening up to week 18
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJP-0035/2-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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