Clinical trial NCT02104388: Safety and Efficacy Study 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 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: 2014-04-04
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 18 and 75 years, inclusive.
* Has moderate to severe superficial punctate keratitis (SPK) and/or corneal erosion in 1 or both eyes.
* Has symptoms caused by corneal epithelial disorders.
* Has not obtained improvement from previous treatment for the SPK or corneal erosion within the last 30 days.
* Is a female of childbearing potential with a negative pregnancy test result at Screening and baseline and agrees to use effective contraception throughout the study or is a postmenopausal woman with a negative pregnancy test result at Screening and baseline.

Exclusion Criteria:

* Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, or chemical burns or any trauma to the cornea.
* Any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures.
* Had previous ocular/refractive surgery (including laser surgery) within the last 6 months.
* Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) within 14 days prior to the first dose of study drug, or who are anticipated to require such medications during the study. Artificial tears may be used up to 72 hours prior to the first dose.
* Is unable to discontinue Restasis. A 28-day washout period prior to the first dose of study drug is required.
* Is a contact lens wearer and cannot discontinue use for the duration of the study.
* Alcohol or drug abuse within the past 6 months.
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus test at Screening.

Primary outcomes:
measure: Clearing of corneal fluorescein staining at week 4
timeFrame: measured at Week 4
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety.
timeFrame: baseline up to week 18
measure: Changes of subjective symptoms: blurred vision, photophobia and eye irritation
timeFrame: screening up to week 18
measure: Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea
timeFrame: screening up to week 18
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Senju Investigational Site
state: Arkansas
city: Glendale
country: United States
facility: Senju Investigational Site
state: California
city: Glendora
country: United States
facility: Senju Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Senju Investigational Site
state: California
city: Lancaster
country: United States
facility: Senju Investigational Site
state: California
city: Newport Beach
country: United States
facility: Senju Investigational Site
state: California
city: Pasadena
country: United States
facility: Senju Investigational Site
state: California
city: Petaluma
country: United States
facility: Senju Investigational Site
state: California
city: Santa Maria
country: United States
facility: Senju Investigational Site
state: California
city: Hoffman Estates
country: United States
facility: Senju Investigational Site
state: Illinois
city: Edgewood
country: United States
facility: Senju Investigational site
state: Kentucky
city: Kansas City
country: United States
facility: Senju Investigational Site
state: Missouri
city: Palisades Park
country: United States
facility: Senju Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Senju Investiational Site
state: New York
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: Norfolk
country: United States
facility: Senju Investigational Site
state: Virginia
Study officials:
References: