Corneal Epithelial Disorders Clinical Trial
Official title:
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
Verified date | March 2021 |
Source | Senju Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | August 4, 2015 |
Est. primary completion date | August 4, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Senju Investigational site | Edgewood | Kentucky |
United States | Senju Investigational Site | Glendale | California |
United States | Senju Investigational Site | Glendora | California |
United States | Senju Investigational Site | High Point | North Carolina |
United States | Senju Investigational Site | Hoffman Estates | Illinois |
United States | Senju Investigational Site | Huntington Beach | California |
United States | Senju Investigational Site | Kansas City | Missouri |
United States | Senju Investigational Site | Lancaster | California |
United States | Senju Investigational Site | Little Rock | Arkansas |
United States | Senju Investigational Site | Newport Beach | California |
United States | Senju Investigational Site | Norfolk | Virginia |
United States | Senju Investigational Site | Palisades Park | New Jersey |
United States | Senju Investigational Site | Pasadena | California |
United States | Senju Investigational Site | Petaluma | California |
United States | Senju Investigational Site | Rapid City | South Dakota |
United States | Senju Investiational Site | Rochester | New York |
United States | Senju Investigational Site | Santa Maria | California |
Lead Sponsor | Collaborator |
---|---|
Senju Pharmaceutical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clearing of corneal fluorescein staining at week 4 | A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared. | measured at Week 4 | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety. | 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. | baseline up to week 18 | |
Secondary | Changes of subjective symptoms: blurred vision, photophobia and eye irritation | 100-point assessments are performed for the symptom of blurred vision, photophobia and eye irritation. | screening up to week 18 | |
Secondary | Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea | These changes are measured at every study visit using standard ophthalmology procedures. | screening up to week 18 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02929823 -
Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
|
Phase 2 |