Dry Eye SyndromePhase 3NCT05245604
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
A Phase 3 study testing TJO-087 and Cyclosporine ophthalmic solution 0.05% in people with Dry Eye Syndrome, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- TJO-087 and Cyclosporine ophthalmic solution 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2020to Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 20 or over
- Patients with moderate to severe dry eye
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Who cannot join
- Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
- Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)> 25 mmHg
- Patient using or to use punctual plug within 1 months.
- Patients with contact lens.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hyo Myung, Kim
Seoul
Hyo Myung Kim, MD, PhD
About this study
Official title: A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.
- Conditions
- Dry Eye Syndrome
- Being tested
- TJO-087, Cyclosporine ophthalmic solution 0.05%
- 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
Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily
Cyclosporine ophthalmic solution 0.05%Drug
Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day
| Study group | Role | What they receive |
|---|---|---|
| TJO-087 | Experimental | Not described Receives: Drug: TJO-087 |
| Cyclosporine 0.05% | Active comparator | Not described Receives: Drug: Cyclosporine ophthalmic solution 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Non-anesthetic Schirmer Test at Week 32
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 32
Secondary outcomes (2)
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24
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, Week 8, 16 and 24
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.
Measured: Baseline, Week 8, 16, 24 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start19 Jun 2020
- Primary completionAug 2022 (estimated)
- Study completionApr 2023 (estimated)
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 Eye SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo Myung Kim, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245604
- Sponsor's protocol ID
- TJO-087-301
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eom Y, Yoon KC, Kim HK, Song JS, Hyon JY, Kim HM. A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):27-35. doi: 10.1089/jop.2022.0119. Epub 2022 Nov 24.
PubMed 36450107
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
- ClinicalTrials.gov ID
- NCT05245604
- Acronym / sponsor ID
- TJO-087-301
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 18 Feb 2022 (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.
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJO-087 | Experimental | Drug: TJO-087 |
| Cyclosporine 0.05% | Active comparator | Drug: Cyclosporine ophthalmic solution 0.05% |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 20 or over
- Patients with moderate to severe dry eye
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Key exclusion criteria (5 listed)
- Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
- Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)> 25 mmHg
- Patient using or to use punctual plug within 1 months.
- 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-087Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily | Drug | TJO-087 |
| Cyclosporine ophthalmic solution 0.05%Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day | Drug | Cyclosporine 0.05% |
Primary outcome
Change From Baseline in Non-anesthetic Schirmer Test at Week 32
Time frame: Baseline and Week 32
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
2 secondary outcomes
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24
Time frame: Baseline, Week 8, 16 and 24
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32
Time frame: Baseline, Week 8, 16, 24 and 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 36450107Eom Y, Yoon KC, Kim HK, Song JS, Hyon JY, Kim HM. A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):27-35. doi: 10.1089/jop.2022.0119. Epub 2022 Nov 24.
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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.
Hyo Myung Kim, MD, PhD principal investigator
Korea University Anam Hospital
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-087 and Cyclosporine ophthalmic solution 0.05% in people with Dry Eye Syndrome, 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 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: status not confirmed, as of the sponsor's last update on 18 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sukyoung Kwon (82-2-799-0184, skkwon@taejoon.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Non-anesthetic Schirmer Test at Week 32 (time frame: Baseline and Week 32). 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 NCT05245604, 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 18 Feb 2022.