Dry Eye SyndromesPhase 3NCT03527212
A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
A Phase 3 study testing SJP-0035 0.001% in people with Dry Eye Syndromes, run by Senju Pharmaceutical Co., Ltd. at 23 sites in United States.
Trial summary
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- SJP-0035 0.001%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 23 sitesUnited States
- Study dates
- 20 Aug 2018to 15 Mar 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form (ICF).
- Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
- Has blurred vision caused by DED in both eyes.
- Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
- Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.
Who cannot join
- Has any corneal stromal or endothelial abnormalities in either eye.
- Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
- Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
- Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
- Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
- Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration of the study.
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- Has previously received SJP-0035 (study drug) in either eye.
- Currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at Screening through the duration of the study.
- Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Chu Vision Institute, 9117 Lyndale Avenue South
Bloomington, Minnesota, 55420
Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
Boynton Beach, Florida, 33437
Hill Country Eye Center
Cedar Park, Texas, 78613
Arizona Eye Center, 1500 West Ray Road
Chandler, Arizona, 85224
Cornerstone Eye Care
High Point, North Carolina, 27262
Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
Hoffman Estates, Illinois, 60169
Alkek Eye Center, 1977 Butler Boulevard
Houston, Texas, 77030
Tauber Eye Center, Suite 202, 4400 Broadway
Kansas City, Missouri, 64111
Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
Las Vegas, Nevada, 89119
SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
Long Beach, California, 90805
East West Eye Institute, 420 East 3rd Street, Suite 603
Los Angeles, California, 90013
The Eye Care Institute, 1536 Story Avenue
Louisville, Kentucky, 40206
Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
Lynbrook, New York, 11563
North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
Mission Hills, California, 91345
Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
Morrow, Georgia, 30260
Virginia Eye Consultants, 241 Corporate Boulevard
Norfolk, Virginia, 23502
North Bay Eye Associates, Inc., 104 Lynch Creek Way
Petaluma, California, 94954
Black Hills Regional Eye Institute, 2800 3rd Street
Rapid City, South Dakota, 57701
Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
Roswell, Georgia, 30076
R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
San Antonio, Texas, 78229
Southern Utah Medical Research, Suite 100, 292 South 1470 East
St. George, Utah, 84790
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
Sun City, Arizona, 85351
South Shore Eye Care LLC, 2185 West Wantagh Avenue
Wantagh, New York, 11793
About this study
Official title: A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients With Dry Eye Disease (DELTA-1 Study)
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo
Read the detailed description
There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.
- Conditions
- Dry Eye Syndromes
- Being tested
- SJP-0035 0.001%, Placebo
- Keywords
- Dry Eye Disease, Corneal Epithelial Disorders, Re-Epithelialization
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJP-0035 0.001%Drug
Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
PlaceboDrug
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| SJP-0035 0.001% (ophthalmic solution) | Experimental | Not described Receives: Drug: SJP-0035 0.001% |
| Placebo (ophthalmic solution) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
Measured: Week 5
Secondary outcomes (1)
Blurred vision
Improvement in blurred vision from baseline, using a 100-point visual analog score (VAS) where 0 indicates no blurred vision and 100 indicates the worst possible blurred vision.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start20 Aug 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 329 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
- NCT03527212
- Sponsor's protocol ID
- SJP-0035/3-01
- Status last verified
- Apr 2019
- First submitted
- 4 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. 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 to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients With Dry Eye Disease (DELTA-1 Study)
- ClinicalTrials.gov ID
- NCT03527212
- Acronym / sponsor ID
- SJP-0035/3-01
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Disease, Corneal Epithelial Disorders, Re-Epithelialization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 17 May 2018 (actual)
- 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.
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo
Detailed description
There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SJP-0035 0.001% (ophthalmic solution) | Experimental | Drug: SJP-0035 0.001% |
| Placebo (ophthalmic solution) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form (ICF).
- Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
- Has blurred vision caused by DED in both eyes.
- Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
- Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.
Key exclusion criteria (9 listed)
- Has any corneal stromal or endothelial abnormalities in either eye.
- Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
- Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
- Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
- Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
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 0.001%Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks | Drug | SJP-0035 0.001% (ophthalmic solution) |
| PlaceboSelf-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks | Drug | Placebo (ophthalmic solution) |
Primary outcome
Corneal fluorescein staining
Time frame: Week 5
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
1 secondary outcome
Blurred vision
Time frame: Week 5
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 16 Apr 2019.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SJP-0035 0.001% in people with Dry Eye Syndromes, run by Senju Pharmaceutical Co., Ltd. at 23 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 9 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Corneal fluorescein staining (time frame: Week 5). 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 16 Apr 2019.