Dry Eye SyndromesPhase 2NCT01558999
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
A Phase 2 study testing High concentration SI-614 and Low concentration SI-614 in people with Dry Eye Syndromes, run by Seikagaku Corporation at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye 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?
- High concentration SI-614 and Low concentration SI-614
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Have provided written informed consent
- Have dry eye in both eyes
Who cannot join
- Use of contact lenses
- Have an uncontrolled systemic disease
- Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
- Women who is pregnant, nursing or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye
- Conditions
- Dry Eye Syndromes
- Being tested
- High concentration SI-614, Low concentration SI-614, Vehicle
- 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.
High concentration SI-614Drug
1 drop in each eye 4 times a day
Low concentration SI-614Drug
1 drop in each eye 4 times a day
VehicleDrug
1 drop in each eye 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| High concentration SI-614 | Experimental | Not described Receives: Drug: High concentration SI-614 |
| Low concentration SI-614 | Experimental | Not described Receives: Drug: Low concentration SI-614 |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in TFBUT
Measured: Day 27
Mean change from baseline in symptom score
Measured: Day 21 - 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seikagaku Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558999
- Sponsor's protocol ID
- 614/1121
- Status last verified
- May 2023
- First submitted
- 18 Mar 2012
- Last updated
- 11 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT01558999
- Acronym / sponsor ID
- 614/1121
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- First posted
- 20 Mar 2012 (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 this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High concentration SI-614 | Experimental | Drug: High concentration SI-614 |
| Low concentration SI-614 | Experimental | Drug: Low concentration SI-614 |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age
- Have provided written informed consent
- Have dry eye in both eyes
Key exclusion criteria (4 listed)
- Use of contact lenses
- Have an uncontrolled systemic disease
- Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
- Women who is pregnant, nursing or planning a pregnancy
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 concentration SI-6141 drop in each eye 4 times a day | Drug | High concentration SI-614 |
| Low concentration SI-6141 drop in each eye 4 times a day | Drug | Low concentration SI-614 |
| Vehicle1 drop in each eye 4 times a day | Drug | Vehicle |
Primary outcome
Mean change from baseline in TFBUT
Time frame: Day 27
Mean change from baseline in symptom score
Time frame: Day 21 - 27
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 11 May 2023.
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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.
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 High concentration SI-614 and Low concentration SI-614 in people with Dry Eye Syndromes, run by Seikagaku Corporation at 1 site 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 3 inclusion and 4 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 11 May 2023. 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 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?
Mean change from baseline in TFBUT (time frame: Day 27). The study lists 2 primary outcomes in all. 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 11 May 2023.