Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929823
• Other study ID #: SJP-0035/2-02
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: May 3, 2017

Study information

• Verified date: May 2018
• Source: Senju Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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%).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Corneal Epithelial Disorders
• Disease

Intervention

Drug:
• High Dose SJP-0035 Ophthalmic Solution
0.001% SJP-0035 Ophthalmic Solution
• Low Dose SJP-0035 Ophthalmic Solution
0.0002% SJP-0035 Ophthalmic Solution
• Vehicle of SJP-0035 Ophthalmic solution
0% SJP-0035 Ophthalmic Solution

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Senju Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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