Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104388
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Senju Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Corneal Epithelial Disorders Drug: SJP-0035 Ophthalmic Solution Drug: Vehicle of SJP-0035 Ophthalmic Solution Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: SJP-0035 Ophthalmic Solution
Patients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
Drug: SJP-0035 Ophthalmic Solution
Placebo Comparator: Vehicle of SJP-0035 Ophthalmic Solution
Patients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
Drug: Vehicle of SJP-0035 Ophthalmic Solution



Primary Outcome Measures :
  1. Clearing of corneal fluorescein staining at week 4 [ Time Frame: measured at Week 4 ]
    A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety. [ Time Frame: baseline up to week 18 ]
    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.

  2. Changes of subjective symptoms: blurred vision, photophobia and eye irritation [ Time Frame: screening up to week 18 ]
    100-point assessments are performed for the symptom of blurred vision, photophobia and eye irritation.

  3. Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea [ Time Frame: screening up to week 18 ]
    These changes are measured at every study visit using standard ophthalmology procedures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104388


Locations
Layout table for location information
United States, Arkansas
Senju Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Senju Investigational Site
Glendale, California, United States, 91206
Senju Investigational Site
Glendora, California, United States, 91741
Senju Investigational Site
Huntington Beach, California, United States, 92647
Senju Investigational Site
Lancaster, California, United States, 93534
Senju Investigational Site
Newport Beach, California, United States, 92663
Senju Investigational Site
Pasadena, California, United States, 91107
Senju Investigational Site
Petaluma, California, United States, 94954
Senju Investigational Site
Santa Maria, California, United States, 93454
United States, Illinois
Senju Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Kentucky
Senju Investigational site
Edgewood, Kentucky, United States, 41017
United States, Missouri
Senju Investigational Site
Kansas City, Missouri, United States, 64111
United States, New Jersey
Senju Investigational Site
Palisades Park, New Jersey, United States, 07650
United States, New York
Senju Investiational Site
Rochester, New York, United States, 14642
United States, North Carolina
Senju Investigational Site
High Point, North Carolina, United States, 27262
United States, South Dakota
Senju Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Virginia
Senju Investigational Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Senju Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Senju Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02104388     History of Changes
Other Study ID Numbers: SJP-0035/2-01
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Pathologic Processes
Ophthalmic Solutions
Pharmaceutical Solutions