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

• Status: Completed
• Trial end date: 2015-08-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Senju Pharmaceutical Co., Ltd.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.