Clinical trial NCT02929823: Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Epithelial Disorders
Lead sponsor: Senju Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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%).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Senju Investigational Site
state: Arkansas
city: Glendora
country: United States
facility: Senju Investigational Site
state: California
city: Lancaster
country: United States
facility: Senju Investigational Site
state: California
city: Long Beach
country: United States
facility: Senju Investigational Site
state: California
city: Montebello
country: United States
facility: Senju Investigational Site
state: California
city: Pasadena
country: United States
facility: Senju Investigational Site
state: California
city: Santa Ana
country: United States
facility: Senju Investigational Site
state: California
city: Miami
country: United States
facility: Senju Investigational Site
state: Florida
city: Hoffman Estates
country: United States
facility: Senju Investigational Site
state: Illinois
city: Edgewood
country: United States
facility: Senju Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Senju Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: Senju Investigational Site
state: Missouri
city: High Point
country: United States
facility: Senju Investigational Site
state: North Carolina
city: Rapid City
country: United States
facility: Senju Investigational Site
state: South Dakota
city: Cedar Park
country: United States
facility: Senju Investigational Site
state: Texas
city: Houston
country: United States
facility: Senju Investigational Site
state: Texas
city: Irving
country: United States
facility: Senju Investigational Site
state: Texas
city: Falls Church
country: United States
facility: Senju Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Senju Investigational Site
state: Virginia
Study officials:
References: