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 Two Dose Concentrations of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders
Verified date | May 2018 |
Source | Senju Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | May 3, 2017 |
Est. primary completion date | May 3, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Senju Investigational Site | Cedar Park | Texas |
United States | Senju Investigational Site | Edgewood | Kentucky |
United States | Senju Investigational Site | Falls Church | Virginia |
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 | Houston | Texas |
United States | Senju Investigational Site | Irving | Texas |
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 | Long Beach | California |
United States | Senju Investigational Site | Louisville | Kentucky |
United States | Senju Investigational Site | Miami | Florida |
United States | Senju Investigational Site | Montebello | California |
United States | Senju Investigational Site | Norfolk | Virginia |
United States | Senju Investigational Site | Pasadena | California |
United States | Senju Investigational Site | Rapid City | South Dakota |
United States | Senju Investigational Site | Santa Ana | California |
Lead Sponsor | Collaborator |
---|---|
Senju Pharmaceutical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 | A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared | 5 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02104388 -
Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
|
Phase 2 |