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Completed

NCT Number: NCT02104388

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

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.

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Key information

Conditions

Corneal Epithelial Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Senju Investigational Site, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SJP-0035 Ophthalmic Solution

Drug

Vehicle of SJP-0035 Ophthalmic Solution

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Senju Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2014
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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