Dry Eye Syndrome (DES)Phase 2NCT07810972
Evaluate the Safety and Efficacy of TJO-087
A Phase 2 study testing TJO-087 in people with Dry Eye Syndrome (DES), run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES)
- What is being tested?
- TJO-087
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥20 years (male or female)
- Patients with dry eye symptoms
- Fluorescein corneal staining score(NEI scale) ≥4
- Schirmer test result (without anesthesia) ≤10 mm/5 min in
- Tear film break-up time (TBUT) <10 seconds
Who cannot join
- Presence or history of systemic or ocular disorder or condition that could affect the interpretation of study results
- Intraocular pressure (IOP) >21 mmHg
- Planned use of contact lenses during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TJO-087
This study aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from baseline.
- Conditions
- Dry Eye Syndrome (DES)
- Being tested
- TJO-087, Vehicle (Placebo solution)
- Keywords
- Dry eye syndrome
- 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.
TJO-087Drug
one drop in each eye, twice daily (1 drop of IP, 1 drop of placebo)
TJO-087Drug
one drop in each eye, twice daily (2 dose of IP)
Vehicle (Placebo solution)Drug
one drop in each eye, twice daily (2 dose of placebo)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | Investigational product QD Receives: Drug: TJO-087 |
| Experimental group B | Experimental | Investigational product BID Receives: Drug: TJO-087 |
| Placebo | Placebo comparator | Placebo BID Receives: Drug: Vehicle (Placebo solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Corneal Staining Score at 12 weeks
Change from Baseline in corneal staining using blue fluorescein staining procedure at 12 weeks.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start6 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810972
- Sponsor's protocol ID
- TJO-087-A02
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TJO-087
- ClinicalTrials.gov ID
- NCT07810972
- Acronym / sponsor ID
- TJO-087-A02
- Conditions
- Dry Eye Syndrome (DES)
- Keywords
- Dry eye syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (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 aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from baseline.
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 |
|---|---|---|
| Experimental group A | Experimental | Drug: TJO-087Investigational product QD |
| Experimental group B | Experimental | Drug: TJO-087Investigational product BID |
| Placebo | Placebo comparator | Drug: Vehicle (Placebo solution)Placebo BID |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥20 years (male or female)
- Patients with dry eye symptoms
- Fluorescein corneal staining score(NEI scale) ≥4
- Schirmer test result (without anesthesia) ≤10 mm/5 min in
- Tear film break-up time (TBUT) <10 seconds
Key exclusion criteria (3 listed)
- Presence or history of systemic or ocular disorder or condition that could affect the interpretation of study results
- Intraocular pressure (IOP) >21 mmHg
- Planned use of contact lenses during the study period
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 |
|---|---|---|
| TJO-087one drop in each eye, twice daily (1 drop of IP, 1 drop of placebo) | Drug | Experimental group A |
| TJO-087one drop in each eye, twice daily (2 dose of IP) | Drug | Experimental group B |
| Vehicle (Placebo solution)one drop in each eye, twice daily (2 dose of placebo) | Drug | Placebo |
Primary outcome
Change From Baseline in Corneal Staining Score at 12 weeks
Time frame: Week 12
Change from Baseline in corneal staining using blue fluorescein staining procedure at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
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 TJO-087 in people with Dry Eye Syndrome (DES), run by Taejoon 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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 in Corneal Staining Score at 12 weeks (time frame: Week 12). 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 9 Sep 2026.