Dry Eye DiseasePhase 3NCT04548427
Study to Evaluate the Efficacy and Safety of CKD-352
A Phase 3 study testing CKD-352 and Diquafosol Sodium 3% in people with Dry Eye Disease, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- CKD-352 and Diquafosol Sodium 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2020to 7 May 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than the age of 19 years old
- Subjects with dry eye symptoms for at least 3 month
- Subjects who sign on an informed consent form willingly
Who cannot join
- Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
- Subjects who have clinically significant medical history of ocular disability
- Subjects who have malignant tumor within 5 years
- Subjects with known hypersensitivity to investigational product
- Women who are nursing, pregnant or planning pregnancy during the study
- Subjects who have received any other investigational product
- Impossible subjects who participate in clinical trial by investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
Read the detailed description
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease
- Conditions
- Dry Eye Disease
- Being tested
- CKD-352, Diquafosol Sodium 3%
- Keywords
- Dry Eye Disease, CKD-352
- 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.
CKD-352Drug
Eye Drop
Diquafosol Sodium 3%Drug
Eye Drop
| Study group | Role | What they receive |
|---|---|---|
| CKD-352 | Experimental | Not described Receives: Drug: CKD-352 |
| Diquafosol Sodium 3% | Active comparator | Not described Receives: Drug: Diquafosol Sodium 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Corneal Staining from Baseline and at Week 4
Measured: Baseline, Week 4
Secondary outcomes (5)
Changes in Corneal Staining from Baseline and at Week 2
Measured: Baseline, Week 2
Changes in Conjunctival Staining from Baseline and at Week 2,4
Measured: Baseline, Week 2,4
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Measured: Baseline, Week 2,4
Changes in Schirmer I Test from Baseline and at Week 2, 4
Measured: Baseline, Week 2,4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Measured: Baseline, Week 2,4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start22 Sep 2020
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong Su Lee, M.D, Ph.D, Study chair, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548427
- Sponsor's protocol ID
- A100_01DED1924
- Status last verified
- May 2021
- First submitted
- 10 Sep 2020
- Last updated
- 1 Jun 2021
- 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 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04548427
- Acronym / sponsor ID
- A100_01DED1924
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye Disease, CKD-352
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 14 Sep 2020 (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 study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
Detailed description
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-352 | Experimental | Drug: CKD-352 |
| Diquafosol Sodium 3% | Active comparator | Drug: Diquafosol Sodium 3% |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than the age of 19 years old
- Subjects with dry eye symptoms for at least 3 month
- Subjects who sign on an informed consent form willingly
Key exclusion criteria (7 listed)
- Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
- Subjects who have clinically significant medical history of ocular disability
- Subjects who have malignant tumor within 5 years
- Subjects with known hypersensitivity to investigational product
- Women who are nursing, pregnant or planning pregnancy during the study
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 |
|---|---|---|
| CKD-352Eye Drop | Drug | CKD-352 |
| Diquafosol Sodium 3%Eye Drop | Drug | Diquafosol Sodium 3% |
Primary outcome
Changes in Corneal Staining from Baseline and at Week 4
Time frame: Baseline, Week 4
5 secondary outcomes
Changes in Corneal Staining from Baseline and at Week 2
Time frame: Baseline, Week 2
Changes in Conjunctival Staining from Baseline and at Week 2,4
Time frame: Baseline, Week 2,4
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Time frame: Baseline, Week 2,4
Changes in Schirmer I Test from Baseline and at Week 2, 4
Time frame: Baseline, Week 2,4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Time frame: Baseline, Week 2,4
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 1 Jun 2021.
- 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.
Jong Su Lee, M.D, Ph.D study chair
Pusan National University 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 CKD-352 and Diquafosol Sodium 3% in people with Dry Eye Disease, run by Chong Kun Dang Pharmaceutical 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 7 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 1 Jun 2021. 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?
Changes in Corneal Staining from Baseline and at Week 4 (time frame: Baseline, Week 4). 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 1 Jun 2021.