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.
There are currently no approved products available anywhere worldwide for the treatment of corneal epithelial disorders that directly affect the epithelia. A Phase 1 study, 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. A Phase 2a study, Study SJP-0035/2-01, was conducted in patients with corneal epithelial disorders to evaluate the efficacy and safety of SJP-0035. This Phase 2a study (Study SJP-0035/2-02) is being conducted to evaluate the safety and efficacy of 2 doses of SJP-0035 ophthalmic solution in patients with corneal epithelial disorders. The study will evaluate if SJP-0035 ophthalmic solution is able to promote corneal epithelial wound healing in patients with corneal epithelial disorders using 2 doses of SJP-0035 ophthalmic solution (0.0002% and 0.001%) that are lower than what was used in the previous Phase 2a study (Study SJP-0035/2-01; 0.005%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
0.001% SJP-0035 Ophthalmic Solution
0.0002% SJP-0035 Ophthalmic Solution
0% SJP-0035 Ophthalmic Solution
Senju Investigational Site
Little Rock, Arkansas, United States
Senju Investigational Site
Glendora, California, United States
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
Time frame: 5 weeks
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Senju Investigational Site
Lancaster, California, United States
Senju Investigational Site
Long Beach, California, United States
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Montebello, California, United States
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Pasadena, California, United States
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Santa Ana, California, United States
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Miami, Florida, United States
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Hoffman Estates, Illinois, United States
Senju Investigational Site
Edgewood, Kentucky, United States
...and 9 more locations