Corneal Epithelial DisordersPhase 2NCT02929823

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

A Phase 2 study testing High Dose SJP-0035 Ophthalmic Solution and Low Dose SJP-0035 Ophthalmic Solution in people with Corneal Epithelial Disorders, run by Senju Pharmaceutical Co., Ltd. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether 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 years and older
Conditions the study is for: Corneal Epithelial Disorders
What is being tested?: High Dose SJP-0035 Ophthalmic Solution and Low Dose SJP-0035 Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 19 sitesUnited States
Study dates: Sep 2016to 3 May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is capable of understanding the written informed consent form (ICF), provides signed and witnessed written ICF, and agrees to comply with protocol requirements, including all required study visits
Is a male or female 18 years of age or older
Has a moderate to severe corneal epithelial disorder in both eyes
Has blurred vision caused by corneal epithelial disorders in both eyes at Screening and Randomization
Is a female of childbearing potential with a negative pregnancy test result at Screening and Randomization and agrees to use effective contraception throughout the study, or is a postmenopausal woman with a negative pregnancy test result at Screening and Randomization

Who cannot join

Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea in either eye at Screening and Randomization
Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures in either eye at Screening and Randomization
Has had intraocular surgery (including cataract or vitreous) in either eye within the last 30 days prior to the first dose of study drug
Has had refractive surgery (including ocular surface laser surgery) in either eye within the last 6 months prior to the first dose of study drug
Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) in either eye within 14 days prior to the first dose of study drug, or is anticipated to require such medications during the study.
Is a contact lens wearer and cannot discontinue use in both eyes from Screening through EOS

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Senju Investigational Site
Cedar Park, Texas, 78613
Senju Investigational Site
Edgewood, Kentucky, 41017
Senju Investigational Site
Falls Church, Virginia, 22044
Senju Investigational Site
Glendora, California, 91741
Senju Investigational Site
High Point, North Carolina, 27262
Senju Investigational Site
Hoffman Estates, Illinois, 60169
Senju Investigational Site
Houston, Texas, 77030
Senju Investigational Site
Irving, Texas, 75039
Senju Investigational Site
Kansas City, Missouri, 64111
Senju Investigational Site
Lancaster, California, 93534
Senju Investigational Site
Little Rock, Arkansas, 72205
Senju Investigational Site
Long Beach, California, 90805
Senju Investigational Site
Louisville, Kentucky, 40206
Senju Investigational Site
Miami, Florida, 33143
Senju Investigational Site
Montebello, California, 90640
Senju Investigational Site
Norfolk, Virginia, 23502
Senju Investigational Site
Pasadena, California, 91107
Senju Investigational Site
Rapid City, South Dakota, 57701
Senju Investigational Site
Santa Ana, California, 92705

Other trials in United States

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 Two Dose Concentrations of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders

The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

Read the detailed description

There are currently no approved products available anywhere worldwide for the treatment of corneal epithelial disorders that directly affect the epithelia.

A Phase 1 study, 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. A Phase 2a study, Study SJP-0035/2-01, was conducted in patients with corneal epithelial disorders to evaluate the efficacy and safety of SJP-0035.

This Phase 2a study (Study SJP-0035/2-02) is being conducted to evaluate the safety and efficacy of 2 doses of SJP-0035 ophthalmic solution in patients with corneal epithelial disorders. The study will evaluate if SJP-0035 ophthalmic solution is able to promote corneal epithelial wound healing in patients with corneal epithelial disorders using 2 doses of SJP-0035 ophthalmic solution (0.0002% and 0.001%) that are lower than what was used in the previous Phase 2a study (Study SJP-0035/2-01; 0.005%).

Conditions: Corneal Epithelial Disorders
Being tested: High Dose SJP-0035 Ophthalmic Solution, Low Dose 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.

High Dose SJP-0035 Ophthalmic SolutionDrug
0.001% SJP-0035 Ophthalmic Solution
Low Dose SJP-0035 Ophthalmic SolutionDrug
0.0002% SJP-0035 Ophthalmic Solution
Vehicle of SJP-0035 Ophthalmic solutionDrug
Also called Placebo
0% SJP-0035 Ophthalmic Solution

Study groups in NCT02929823
Study group	Role	What they receive
Low Dose SJP-0035 Ophthalmic solution	Experimental	Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks. Receives: Drug: Low Dose SJP-0035 Ophthalmic Solution
High Dose SJP-0035 Ophthalmic solution	Experimental	Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks. Receives: Drug: High Dose SJP-0035 Ophthalmic Solution
Vehicle of SJP-0035 Ophthalmic solution	Placebo comparator	Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 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.

Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared
Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 20163 May 2017

First posted11 Oct 2016 (estimated)
Study startSep 2016
Primary completion3 May 2017
Study completion3 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02929823
Sponsor's protocol ID: SJP-0035/2-02
Status last verified: May 2018
First submitted: 7 Oct 2016
Last updated: 13 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 2
Lacripep for Corneal Wound Healing Study
Corneal Epithelial Wound Healing
Recruiting
A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction
Cornea Disease
Not yet recruitingObservational study
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All Corneal Epithelial Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 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 Two Dose Concentrations of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders
ClinicalTrials.gov ID: NCT02929823
Acronym / sponsor ID: SJP-0035/2-02
Conditions: Corneal Epithelial Disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2016 (actual)
Primary completion: 3 May 2017 (actual)
Study completion: 3 May 2017 (actual)
First posted: 11 Oct 2016 (estimated)
Results: Posted 12 Jun 2018

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 this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

Detailed description

There are currently no approved products available anywhere worldwide for the treatment of corneal epithelial disorders that directly affect the epithelia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low Dose SJP-0035 Ophthalmic solution	Experimental	Drug: Low Dose SJP-0035 Ophthalmic SolutionPatients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic solution	Experimental	Drug: High Dose SJP-0035 Ophthalmic SolutionPatients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Vehicle of SJP-0035 Ophthalmic solution	Placebo comparator	Drug: Vehicle of SJP-0035 Ophthalmic solutionPatients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is capable of understanding the written informed consent form (ICF), provides signed and witnessed written ICF, and agrees to comply with protocol requirements, including all required study visits
Is a male or female 18 years of age or older
Has a moderate to severe corneal epithelial disorder in both eyes
Has blurred vision caused by corneal epithelial disorders in both eyes at Screening and Randomization
Is a female of childbearing potential with a negative pregnancy test result at Screening and Randomization and agrees to use effective contraception throughout the study, or is a postmenopausal woman with a negative pregnancy test result at Screening and Randomization

Key exclusion criteria (6 listed)

Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea in either eye at Screening and Randomization
Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures in either eye at Screening and Randomization
Has had intraocular surgery (including cataract or vitreous) in either eye within the last 30 days prior to the first dose of study drug
Has had refractive surgery (including ocular surface laser surgery) in either eye within the last 6 months prior to the first dose of study drug
Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) in either eye within 14 days prior to the first dose of study drug, or is anticipated to require such medications during the study.

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
High Dose SJP-0035 Ophthalmic Solution0.001% SJP-0035 Ophthalmic Solution	Drug	High Dose SJP-0035 Ophthalmic solution
Low Dose SJP-0035 Ophthalmic Solution0.0002% SJP-0035 Ophthalmic Solution	Drug	Low Dose SJP-0035 Ophthalmic solution
Vehicle of SJP-0035 Ophthalmic solutionAlso: Placebo0% SJP-0035 Ophthalmic Solution	Drug	Vehicle of SJP-0035 Ophthalmic solution

Primary outcome

Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5
Time frame: 5 weeks
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared

Results and safety

Results posted to the registry on 12 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	42	39
0.0002% SJP-0035 Ophthalmic Solution	46	40
0.001% SJP-0035 Ophthalmic Solution	42	38

Primary outcome: Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5

Time frame: 5 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 42	0.0002% SJP-0035 Ophthalmic Solution n = 45	0.001% SJP-0035 Ophthalmic Solution n = 42
Value	5	7	12

Population analysed: Full Analysis Set: All patients randomly assigned to receive double-masked study drug, who received at least 1 dose of study drug in the study eye, and who had at least 1 post-baseline assessment for the primary efficacy endpoint.

Adverse events

Time frame: Up to 30 days following final dose (Week 5). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 42 (0%)	10 of 42 (23.8%)	0 of 42
0.0002% SJP-0035 Ophthalmic Solution	0 of 46 (0%)	6 of 46 (13%)	0 of 46
0.001% SJP-0035 Ophthalmic Solution	1 of 42 (2.4%)	15 of 42 (35.7%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Corneal Epithelial Disorders

RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 2
Lacripep for Corneal Wound Healing Study
Corneal Epithelial Wound Healing
Recruiting
A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction
Cornea Disease
Not yet recruitingObservational study
Corneal Epithelial Thickness Mapping by Anterior Segment Optical Coherence Tomography in Patients With Refractive Errors
Myopia, Hyperopia

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.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929823.

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 13 Apr 2021.