Dry EyePhase 4NCT04127851
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients
A Phase 4 study testing TJO-018 (HA 0.15%), Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) and TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05% 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 moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- TJO-018 (HA 0.15%), Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) and TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Nov 2019to 14 Oct 2021
- Phase
- Phase 4
- 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
- Moderate to Severe Dry Eye Disease Patients
- Written informed consent to participate in the trial
Who cannot join
- Any laser or ocular surgery within 2 months prior screening
- Use of contact lenses
- Any condition limiting patient's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients
In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- TJO-018 (HA 0.15%), Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add), TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 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-018 (HA 0.15%)Drug
TJO-018 / one drop / 6 times daily in both eyes
Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)Drug
Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two~six times daily in both eyes
TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%Drug
TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hyaluronate 0.15% mono-therapy | Experimental | HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks Receives: Drug: TJO-018 (HA 0.15%) |
| Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy) | Active comparator | CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two ~ six times daily for 12 weeks. Receives: Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) |
| HA 0.15% + CsA 0.05% (combination therapy) | Other | HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks. Receives: Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05% |
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 Week 12
After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.
- Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe).
- The higher scores mean a worse outcome.
Measured: Baseline and Week 12
Secondary outcomes (1)
Change From Baseline in Corneal Staining Score at Week 4 and Week 8
After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.
- Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe).
- The higher scores mean a worse outcome.
Measured: Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start12 Nov 2019
- Primary completion14 Jul 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 438 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
- NCT04127851
- Sponsor's protocol ID
- TJO-018
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients
- ClinicalTrials.gov ID
- NCT04127851
- Acronym / sponsor ID
- TJO-018
- Conditions
- Dry Eye, Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 16 Oct 2019 (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 moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
| Arm | Type | Receives |
|---|---|---|
| Sodium Hyaluronate 0.15% mono-therapy | Experimental | Drug: TJO-018 (HA 0.15%)HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks |
| Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy) | Active comparator | Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two ~ six times daily for 12 weeks. |
| HA 0.15% + CsA 0.05% (combination therapy) | Other | Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age 20 or over
- Moderate to Severe Dry Eye Disease Patients
- Written informed consent to participate in the trial
Key exclusion criteria (3 listed)
- Any laser or ocular surgery within 2 months prior screening
- Use of contact lenses
- Any condition limiting patient's ability to participate in the trial
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-018 (HA 0.15%)TJO-018 / one drop / 6 times daily in both eyes | Drug | Sodium Hyaluronate 0.15% mono-therapy |
| Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two~six times daily in both eyes | Drug | Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy) |
| TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes | Drug | HA 0.15% + CsA 0.05% (combination therapy) |
Primary outcome
Change From Baseline in Corneal Staining Score at Week 12
Time frame: Baseline and Week 12
After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome.
1 secondary outcome
Change From Baseline in Corneal Staining Score at Week 4 and Week 8
Time frame: Baseline, Week 4 and Week 8
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 8 Jun 2022.
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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 4 study testing TJO-018 (HA 0.15%), Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) and TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05% 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 3 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: finished, as of the sponsor's last update on 8 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Score at Week 12 (time frame: Baseline and 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 8 Jun 2022.