Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
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
1 other identifier
interventional
69
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
April 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2015
CompletedMarch 29, 2021
March 1, 2021
1.3 years
March 19, 2014
March 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Participants with Adverse Events as a Measure of Safety.
baseline up to week 18
Changes of subjective symptoms: blurred vision, photophobia and eye irritation
screening up to week 18
Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea
screening up to week 18
Study Arms (2)
SJP-0035 Ophthalmic Solution
EXPERIMENTALPatients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
Vehicle of SJP-0035 Ophthalmic Solution
PLACEBO COMPARATORPatients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Senju Investigational Site
Little Rock, Arkansas, 72205, United States
Senju Investigational Site
Glendale, California, 91206, United States
Senju Investigational Site
Glendora, California, 91741, United States
Senju Investigational Site
Huntington Beach, California, 92647, United States
Senju Investigational Site
Lancaster, California, 93534, United States
Senju Investigational Site
Newport Beach, California, 92663, United States
Senju Investigational Site
Pasadena, California, 91107, United States
Senju Investigational Site
Petaluma, California, 94954, United States
Senju Investigational Site
Santa Maria, California, 93454, United States
Senju Investigational Site
Hoffman Estates, Illinois, 60169, United States
Senju Investigational site
Edgewood, Kentucky, 41017, United States
Senju Investigational Site
Kansas City, Missouri, 64111, United States
Senju Investigational Site
Palisades Park, New Jersey, 07650, United States
Senju Investiational Site
Rochester, New York, 14642, United States
Senju Investigational Site
High Point, North Carolina, 27262, United States
Senju Investigational Site
Rapid City, South Dakota, 57701, United States
Senju Investigational Site
Norfolk, Virginia, 23502, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
April 4, 2014
Study Start
April 8, 2014
Primary Completion
August 4, 2015
Study Completion
August 4, 2015
Last Updated
March 29, 2021
Record last verified: 2021-03