Dry Eye DiseasePhase 3SIDENCT05411367
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
A Phase 3 study testing SI-614 in people with Dry Eye Disease, run by Seikagaku Corporation at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in 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 Disease
- What is being tested?
- SI-614
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Jul 2022to 27 Apr 2023
- Phase
- Phase 3
- 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
- Have history of dry eye in both eyes for at least 6 months prior to Visit 1.
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1.
- If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period.
Who cannot join
- Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters.
- Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2.
- Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any scheduled ocular surgical procedure during the study period.
- Be a female who is pregnant, nursing an infant, or planning a pregnancy.
- Have a known allergy and/or sensitivity to the study drug or its components.
- Have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Andover Eye Associates, Inc.
Andover, Massachusetts, 01810
Center for Sight
Henderson, Nevada, 89052
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
CORE Inc, Vita Eye Clinic
Shelby, North Carolina, 28150
About this study
Official title: A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
Read the detailed description
This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.
Randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis.
- Conditions
- Dry Eye Disease
- Being tested
- SI-614, Placebo
- 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.
SI-614Drug
Also called Chemically modified sodium hyaluronate
One drop of study drug was instilled in each eye 4 times daily for 84 days
PlaceboDrug
Also called Vehicle
One drop of study drug was instilled in each eye 4 times daily for 84 days
| Study group | Role | What they receive |
|---|---|---|
| SI-614 | Experimental | One drop of study drug was instilled in each eye 4 times daily for 84 days Receives: Drug: SI-614 |
| Placebo | Placebo comparator | One drop of study drug was instilled in each eye 4 times daily for 84 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye
The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome.
The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12.
For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only.
Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo).
Measured: 29 days
Secondary outcomes (1)
Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14
Subjects graded the severity of their dry eye disease symptoms in their diary with rating the severity of 5 symptoms. Each symptom rating ranged from 0 to 5 using whole numbers, where 0 = None and 5 = Worst. Higher numbers indicate worse symptomology.
The average score of the two symptoms of ocular discomfort (where 0 = None and 5 = Worst) and dryness (where 0 = None and 5 = Worst) was measured.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start28 Jul 2022
- Primary completion2 Mar 2023
- Study completion27 Apr 2023
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 Dry Eye DiseaseStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seikagaku Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc., Statistics & Data Corporation
- Responsible party
- Sponsor
- Investigators
- George Ousler, Study director, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411367
- Sponsor's protocol ID
- 614/1132
- Acronym
- SIDE
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2022
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT05411367
- Acronym / sponsor ID
- SIDE / 614/1132
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc., Statistics & Data Corporation
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Posted 16 Jan 2026
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 evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
Detailed description
This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.
Randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis.
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 |
|---|---|---|
| SI-614 | Experimental | Drug: SI-614One drop of study drug was instilled in each eye 4 times daily for 84 days |
| Placebo | Placebo comparator | Drug: PlaceboOne drop of study drug was instilled in each eye 4 times daily for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have history of dry eye in both eyes for at least 6 months prior to Visit 1.
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1.
- If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period.
Key exclusion criteria (6 listed)
- Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters.
- Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2.
- Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any scheduled ocular surgical procedure during the study period.
- Be a female who is pregnant, nursing an infant, or planning a pregnancy.
- Have a known allergy and/or sensitivity to the study drug or its components.
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 |
|---|---|---|
| SI-614Also: Chemically modified sodium hyaluronateOne drop of study drug was instilled in each eye 4 times daily for 84 days | Drug | SI-614 |
| PlaceboAlso: VehicleOne drop of study drug was instilled in each eye 4 times daily for 84 days | Drug | Placebo |
Primary outcome
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye
Time frame: 29 days
The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo).
1 secondary outcome
Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
George Ousler study director
ORA, Inc.
6 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 SI-614 in people with Dry Eye Disease, run by Seikagaku Corporation at 6 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 3 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 16 Jan 2026). 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?
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye (time frame: 29 days). 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 Jan 2026.