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

Completed · Phase 2

Conditions studied: Corneal Epithelial Disorders

In brief

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

Key facts

Study ID

NCT02104388

Run by

Senju Pharmaceutical Co., Ltd.

People needed

69

Starts

2014-04-08

Expected to finish

2015-08-04

Last updated by the study team

2021-03-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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