Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
NCT ID: NCT02104388
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2014-04-08
2015-08-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
SJP-0035 Ophthalmic Solution
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.
Vehicle of SJP-0035 Ophthalmic Solution
Interventions
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SJP-0035 Ophthalmic Solution
Vehicle of SJP-0035 Ophthalmic Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Senju Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Senju Investigational Site
Little Rock, Arkansas, United States
Senju Investigational Site
Glendale, California, United States
Senju Investigational Site
Glendora, California, United States
Senju Investigational Site
Huntington Beach, California, United States
Senju Investigational Site
Lancaster, California, United States
Senju Investigational Site
Newport Beach, California, United States
Senju Investigational Site
Pasadena, California, United States
Senju Investigational Site
Petaluma, California, United States
Senju Investigational Site
Santa Maria, California, United States
Senju Investigational Site
Hoffman Estates, Illinois, United States
Senju Investigational site
Edgewood, Kentucky, United States
Senju Investigational Site
Kansas City, Missouri, United States
Senju Investigational Site
Palisades Park, New Jersey, United States
Senju Investiational Site
Rochester, New York, United States
Senju Investigational Site
High Point, North Carolina, United States
Senju Investigational Site
Rapid City, South Dakota, United States
Senju Investigational Site
Norfolk, Virginia, United States
Countries
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Other Identifiers
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SJP-0035/2-01
Identifier Type: -
Identifier Source: org_study_id
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