Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders

Completed · Phase 2 · Has a placebo group

Conditions studied: Corneal Epithelial Disorders

In brief

The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

Key facts

Study ID

NCT02929823

Run by

Senju Pharmaceutical Co., Ltd.

People needed

130

Starts

2016-09-01

Expected to finish

2017-05-03

Last updated by the study team

2021-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is capable of understanding the written informed consent form (ICF), provides signed and witnessed written ICF, and agrees to comply with protocol requirements, including all required study visits
• Is a male or female 18 years of age or older
• Has a moderate to severe corneal epithelial disorder in both eyes
• Has blurred vision caused by corneal epithelial disorders in both eyes at Screening and Randomization
• Is a female of childbearing potential with a negative pregnancy test result at Screening and Randomization and agrees to use effective contraception throughout the study, or is a postmenopausal woman with a negative pregnancy test result at Screening and Randomization

You may not qualify if…

• Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea in either eye at Screening and Randomization
• Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures in either eye at Screening and Randomization
• Has had intraocular surgery (including cataract or vitreous) in either eye within the last 30 days prior to the first dose of study drug
• Has had refractive surgery (including ocular surface laser surgery) in either eye within the last 6 months prior to the first dose of study drug
• Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) in either eye within 14 days prior to the first dose of study drug, or is anticipated to require such medications during the study.
• Is a contact lens wearer and cannot discontinue use in both eyes from Screening through EOS

Where it is running

• Senju Investigational Site — Little Rock, Arkansas, United States
• Senju Investigational Site — Glendora, California, United States
• Senju Investigational Site — Lancaster, California, United States
• Senju Investigational Site — Long Beach, California, United States
• Senju Investigational Site — Montebello, California, United States
• Senju Investigational Site — Pasadena, California, United States
• Senju Investigational Site — Santa Ana, California, United States
• Senju Investigational Site — Miami, Florida, United States
• Senju Investigational Site — Hoffman Estates, Illinois, United States
• Senju Investigational Site — Edgewood, Kentucky, United States
• Senju Investigational Site — Louisville, Kentucky, United States
• Senju Investigational Site — Kansas City, Missouri, United States
• Senju Investigational Site — High Point, North Carolina, United States
• Senju Investigational Site — Rapid City, South Dakota, United States
• Senju Investigational Site — Cedar Park, Texas, United States
• Senju Investigational Site — Houston, Texas, United States
• Senju Investigational Site — Irving, Texas, United States
• Senju Investigational Site — Falls Church, Virginia, United States
• Senju Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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