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.
There is currently no product approved for corneal epithelial wound healing. A Phase 1 Study SJP-0035/1-01 was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders. This Phase 2a study is being conducted to evaluate the safety and efficacy of SJP-0035 ophthalmic solution in patients to promote corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
69
Senju Investigational Site
Little Rock, Arkansas, United States
Senju Investigational Site
Glendale, California, United States
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.
Time frame: measured at Week 4
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.
Time frame: baseline up to week 18
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.
Time frame: screening up to week 18
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.
Time frame: screening up to week 18
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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
...and 7 more locations