Corneal Epithelial DisordersPhase 2NCT02104388
Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
A Phase 2 study testing SJP-0035 Ophthalmic Solution in people with Corneal Epithelial Disorders, run by Senju Pharmaceutical Co., Ltd. at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Epithelial Disorders
- What is being tested?
- SJP-0035 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 17 sitesUnited States
- Study dates
- 8 Apr 2014to 4 Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Senju Investigational site
Edgewood, Kentucky, 41017
Senju Investigational Site
Glendale, California, 91206
Senju Investigational Site
Glendora, California, 91741
Senju Investigational Site
High Point, North Carolina, 27262
Senju Investigational Site
Hoffman Estates, Illinois, 60169
Senju Investigational Site
Huntington Beach, California, 92647
Senju Investigational Site
Kansas City, Missouri, 64111
Senju Investigational Site
Lancaster, California, 93534
Senju Investigational Site
Little Rock, Arkansas, 72205
Senju Investigational Site
Newport Beach, California, 92663
Senju Investigational Site
Norfolk, Virginia, 23502
Senju Investigational Site
Palisades Park, New Jersey, 07650
Senju Investigational Site
Pasadena, California, 91107
Senju Investigational Site
Petaluma, California, 94954
Senju Investigational Site
Rapid City, South Dakota, 57701
Senju Investiational Site
Rochester, New York, 14642
Senju Investigational Site
Santa Maria, California, 93454
About this study
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
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.
Read the 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.
- Conditions
- Corneal Epithelial Disorders
- Being tested
- SJP-0035 Ophthalmic Solution, Vehicle of SJP-0035 Ophthalmic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJP-0035 Ophthalmic SolutionDrug
Vehicle of SJP-0035 Ophthalmic SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| SJP-0035 Ophthalmic Solution | Experimental | Patients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks. Receives: Drug: SJP-0035 Ophthalmic Solution |
| Vehicle of SJP-0035 Ophthalmic Solution | Placebo comparator | Patients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks. Receives: Drug: Vehicle of SJP-0035 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured at Week 4
Secondary outcomes (3)
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.
Measured: baseline up to week 18
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.
Measured: screening up to week 18
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.
Measured: screening up to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start8 Apr 2014
- Primary completion4 Aug 2015
- Study completion4 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104388
- Sponsor's protocol ID
- SJP-0035/2-01
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2014
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02104388
- Acronym / sponsor ID
- SJP-0035/2-01
- Conditions
- Corneal Epithelial Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 4 Aug 2015 (actual)
- Study completion
- 4 Aug 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SJP-0035 Ophthalmic Solution | Experimental | Drug: SJP-0035 Ophthalmic SolutionPatients 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 comparator | Drug: Vehicle of SJP-0035 Ophthalmic SolutionPatients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SJP-0035 Ophthalmic Solution | Drug | SJP-0035 Ophthalmic Solution |
| Vehicle of SJP-0035 Ophthalmic Solution | Drug | Vehicle of SJP-0035 Ophthalmic Solution |
Primary outcome
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.
3 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety.
Time frame: baseline up to week 18
Changes of subjective symptoms: blurred vision, photophobia and eye irritation
Time frame: screening up to week 18
Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea
Time frame: screening up to week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SJP-0035 Ophthalmic Solution in people with Corneal Epithelial Disorders, run by Senju Pharmaceutical Co., Ltd. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearing of corneal fluorescein staining at week 4 (time frame: measured at Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.