Dry Eye SyndromesPhase 2NCT03723811
Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.
A Phase 2 study testing SJP002 BID and SJP002 QID in people with Dry Eye Syndromes, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- SJP002 BID and SJP002 QID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2017to 26 Jun 2018
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 19.
- Must meet all criteria listed below at least in one eye.
- Fluorescein corneal staining score ≥ 2
- Schirmer test ≤ 10mm in 5 mins
- Tear break-up time ≤ 10 secs
Who cannot join
- Ocular disorder that may confound interpretation of study results.
- Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.
- History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.
- Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.
- Participation in other studies within 30 days of screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye Syndrome.
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
- Conditions
- Dry Eye Syndromes
- Being tested
- SJP002 BID, SJP002 QID, SJP002 Placebo 1, SJP002 Placebo 2
- 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.
SJP002 BIDDrug
1 drop b.i.d for 12 weeks
SJP002 QIDDrug
1 drop q.i.d for 12 weeks
SJP002 Placebo 1Drug
1 drop q.i.d for 12 weeks
SJP002 Placebo 2Drug
1 drop q.i.d for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SJP002 BID Receives: Drug: SJP002 BID |
| 2 | Experimental | SJP002 QID Receives: Drug: SJP002 QID |
| Placebo 1 | Placebo comparator | SJP002 Placebo 1 Receives: Drug: SJP002 Placebo 1 |
| Placebo 2 | Placebo comparator | SJP002 Placebo 2 Receives: Drug: SJP002 Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Fluorescein Corneal Staining(FCS) score
The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, >E).
Measured: 4 weeks
Secondary outcomes (6)
Change from baseline of Fluorescein Corneal Staining(FCS) score
The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, >E).
Measured: 2 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Immediately after dyeing (max within 2 minutes), Scored by using slit lamp on white light and a red barrier filte according to the Oxford scheme using a source From 0 (no staining, A) up to 5 (severe, confluent staining, >E) (10 points in total).
Measured: 2, 4 weeks
Change from baseline of Schirmer Test score
Change from Baseline, 2, 4 Weeks
Measured: 2, 4 weeks
Change from baseline of Tear Break-Up Time(TBUT)
Change from Baseline, 2, 4 Weeks
Measured: 2, 4 weeks
Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)
Change from Baseline, 4 Weeks
Measured: 4 weeks
Numbers of used artificial tears during the study period
Change from Baseline, 4 Weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start28 Nov 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choun-Ki Joo, M.D.,Ph.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723811
- Sponsor's protocol ID
- SJSJP002_02
- Status last verified
- Mar 2022
- First submitted
- 26 Oct 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye Syndrome.
- ClinicalTrials.gov ID
- NCT03723811
- Acronym / sponsor ID
- SJSJP002_02
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 30 Oct 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.
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SJP002 BIDSJP002 BID |
| 2 | Experimental | Drug: SJP002 QIDSJP002 QID |
| Placebo 1 | Placebo comparator | Drug: SJP002 Placebo 1SJP002 Placebo 1 |
| Placebo 2 | Placebo comparator | Drug: SJP002 Placebo 2SJP002 Placebo 2 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 19.
- Must meet all criteria listed below at least in one eye.
Key exclusion criteria (5 listed)
- Ocular disorder that may confound interpretation of study results.
- Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.
- History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.
- Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.
- Participation in other studies within 30 days of screening visit.
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 |
|---|---|---|
| SJP002 BID1 drop b.i.d for 12 weeks | Drug | 1 |
| SJP002 QID1 drop q.i.d for 12 weeks | Drug | 2 |
| SJP002 Placebo 11 drop q.i.d for 12 weeks | Drug | Placebo 1 |
| SJP002 Placebo 21 drop q.i.d for 12 weeks | Drug | Placebo 2 |
Primary outcome
Change from baseline of Fluorescein Corneal Staining(FCS) score
Time frame: 4 weeks
The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, >E).
6 secondary outcomes
Change from baseline of Fluorescein Corneal Staining(FCS) score
Time frame: 2 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Time frame: 2, 4 weeks
Change from baseline of Schirmer Test score
Time frame: 2, 4 weeks
Change from baseline of Tear Break-Up Time(TBUT)
Time frame: 2, 4 weeks
Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)
Time frame: 4 weeks
Numbers of used artificial tears during the study period
Time frame: 4 weeks
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 7 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Choun-Ki Joo, M.D.,Ph.D. principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SJP002 BID and SJP002 QID in people with Dry Eye Syndromes, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 5 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Change from baseline of Fluorescein Corneal Staining(FCS) score (time frame: 4 weeks). 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 7 Apr 2022.