Safety and Efficacy Study 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 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: NCT02104388
• Other study ID #: SJP-0035/2-01
• Status: Completed
• Phase: Phase 2
• Start date: April 8, 2014
• Est. completion date: August 4, 2015

Study information

• Verified date: March 2021
• Source: Senju Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 4, 2015
• Est. primary completion date: August 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Epithelial Disorders
• Disease

Intervention

Drug:
• SJP-0035 Ophthalmic Solution

• Vehicle of SJP-0035 Ophthalmic Solution

Locations

Country	Name	City	State
United States	Senju Investigational site	Edgewood	Kentucky
United States	Senju Investigational Site	Glendale	California
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	Huntington Beach	California
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	Newport Beach	California
United States	Senju Investigational Site	Norfolk	Virginia
United States	Senju Investigational Site	Palisades Park	New Jersey
United States	Senju Investigational Site	Pasadena	California
United States	Senju Investigational Site	Petaluma	California
United States	Senju Investigational Site	Rapid City	South Dakota
United States	Senju Investiational Site	Rochester	New York
United States	Senju Investigational Site	Santa Maria	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	Clearing of corneal fluorescein staining at week 4	A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared.	measured at Week 4
Secondary	Number of Participants with Adverse Events as a Measure of Safety.	An Adverse Event is defined as any untoward medical occurrence in a patient enrolled into the study regardless of its causal relationship to study drug.	baseline up to week 18
Secondary	Changes of subjective symptoms: blurred vision, photophobia and eye irritation	100-point assessments are performed for the symptom of blurred vision, photophobia and eye irritation.	screening up to week 18
Secondary	Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea	These changes are measured at every study visit using standard ophthalmology procedures.	screening up to week 18