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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
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.
Details
| Lead sponsor | Senju Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 130 |
| Start date | 2016-09 |
| Completion | 2017-05-03 |
Conditions
- Corneal Epithelial Disorders
Interventions
- High Dose SJP-0035 Ophthalmic Solution
- Low Dose SJP-0035 Ophthalmic Solution
- Vehicle of SJP-0035 Ophthalmic solution
Primary outcomes
- Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 — 5 weeks
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared
Countries
United States