Dry EyePhase 3NCT06427031
Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
A Phase 3 study testing TJO-083 and Diquafosol ophthalmic sodium solution 3% in people with Dry Eye and Dry Eye Syndromes, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- TJO-083 and Diquafosol ophthalmic sodium solution 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2023to 3 Jul 2024
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 20 or over
- Has dry eye symptoms (minimum 3 months)
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Who cannot join
- The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
- The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
- Intraocular pressure(IOP)> 21 mmHg
- Patients with contact lens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- TJO-083, Diquafosol ophthalmic sodium solution 3%
- 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-083Drug
Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Diquafosol ophthalmic sodium solution 3%Drug
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day
| Study group | Role | What they receive |
|---|---|---|
| TJO-083 | Experimental | TJO-083 : 1 drop 3 times a day Receives: Drug: TJO-083 |
| Diquas-s Ophthalmic solution 3% 0.4mL | Active comparator | 1 drop 6 times a day Receives: Drug: Diquafosol ophthalmic sodium solution 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Corneal Staining at Week 4
Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.
Measured: Baseline and Week 4
Secondary outcomes (3)
Change From Baseline in Corneal Staining at Week 8, 12
Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.
Measured: Baseline and Week 8 and 12
Change From Baseline in Conjunctival Staining at Week 4, 8 and 12
Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12
Measured: Baseline and Week 4, 8 and 12
Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Measured: Baseline and Week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start14 Jul 2023
- Primary completion22 May 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Model description
- A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 271 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
- NCT06427031
- Sponsor's protocol ID
- TJO-083-A03
- Status last verified
- Apr 2025
- First submitted
- 19 May 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HK, Kim TI, Song JS, Kim MK, Lee H, Yoon KC, Na KS, Ji YW, Lee JE, Kim HK. Three-Times-Daily 5% Diquafosol Versus Six-Times-Daily 3% Diquafosol for Dry Eye Disease: A Randomized, Double-Masked, Multicenter Phase 3 Noninferiority Trial. J Ocul Pharmacol Ther. 2026 Nov 2:10807683261496778. doi: 10.1177/10807683261496778. Online ahead of print.
PubMed 42968636
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
- ClinicalTrials.gov ID
- NCT06427031
- Acronym / sponsor ID
- TJO-083-A03
- Conditions
- Dry Eye, Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 23 May 2024 (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.
In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome
| Arm | Type | Receives |
|---|---|---|
| TJO-083 | Experimental | Drug: TJO-083TJO-083 : 1 drop 3 times a day |
| Diquas-s Ophthalmic solution 3% 0.4mL | Active comparator | Drug: Diquafosol ophthalmic sodium solution 3%1 drop 6 times a day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 20 or over
- Has dry eye symptoms (minimum 3 months)
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Key exclusion criteria (4 listed)
- The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
- The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
- Intraocular pressure(IOP)> 21 mmHg
- Patients with contact lens
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-083Diquafosol ophthalmic sodium solution, 1 drop 3 times a day | Drug | TJO-083 |
| Diquafosol ophthalmic sodium solution 3%Diquafosol ophthalmic sodium solution, 1 drop 6 times a day | Drug | Diquas-s Ophthalmic solution 3% 0.4mL |
Primary outcome
Change From Baseline in Corneal Staining at Week 4
Time frame: Baseline and Week 4
Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.
3 secondary outcomes
Change From Baseline in Corneal Staining at Week 8, 12
Time frame: Baseline and Week 8 and 12
Change From Baseline in Conjunctival Staining at Week 4, 8 and 12
Time frame: Baseline and Week 4, 8 and 12
Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12
Time frame: Baseline and Week 4, 8 and 12
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 22 Apr 2025.
- Derived from this study: PubMed 42968636Lee HK, Kim TI, Song JS, Kim MK, Lee H, Yoon KC, Na KS, Ji YW, Lee JE, Kim HK. Three-Times-Daily 5% Diquafosol Versus Six-Times-Daily 3% Diquafosol for Dry Eye Disease: A Randomized, Double-Masked, Multicenter Phase 3 Noninferiority Trial. J Ocul Pharmacol Ther. 2026 Nov 2:10807683261496778. doi: 10.1177/10807683261496778. Online ahead of print.
- 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 3 study testing TJO-083 and Diquafosol ophthalmic sodium solution 3% in people with Dry Eye and Dry Eye Syndromes, 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 4 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 22 Apr 2025. 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. 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?
Change From Baseline in Corneal Staining at Week 4 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427031, which also lists 1 linked publication.
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 22 Apr 2025.