Primary Open Angle GlaucomaPhase 2NCT04448223
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
A Phase 2 study testing CKD-351 and Latanoprost+Dorzolmamide in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of CKD-351 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- CKD-351 and Latanoprost+Dorzolmamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2020to 5 Dec 2022
- Phase
- Phase 2
- 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 who has primary open-angle glaucoma or ocular hypertension
- Subjects who sign on an informed consent form willingly
Who cannot join
- Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
- Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
- Subjects who were diagnosed as below
- Aphakia
- Intraocular lens
- Acute or Chronic Closed-Angle Glaucoma
Show all 10Show fewer
- Secondary Glaucoma
- Subjects with ocular inflammation or infection within the last 3 months
- Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
- Subjects who received topical or systemic steroids within the last 1 month.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
KiHo Park, MD
About this study
Official title: Multi Center, Randomized, Open-label, Active Controlled, Phase 2 Trial, Proof Of Concept Study to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
The purpose of this study is to evaluate efficacy and safety of CKD-351
Read the detailed description
Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- CKD-351, Latanoprost+Dorzolmamide
- Keywords
- Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-351Drug
Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
Latanoprost+DorzolmamideDrug
Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
| Study group | Role | What they receive |
|---|---|---|
| CKD-351 | Experimental | CKD-351 Receives: Drug: CKD-351 |
| Latanoprost+Dorzolamide | Active comparator | Latanoprost(50ul/ml) Dorzolmamide(20mg/ml) Receives: Drug: Latanoprost+Dorzolmamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean intraocular pressure for efficacy measurement
Change in mean intraocular pressure at 4 weeks compared to baseline
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Change in mean intraocular pressure for efficacy measurement
Change in mean intraocular pressure at 2 weeks compared to baseline
Measured: Baseline, 2 weeks
Changes in intraocular pressure for efficacy measurement
Intraocular pressure by each measurement time
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start11 Jun 2020
- Primary completion5 Dec 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KiHo Park, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448223
- Sponsor's protocol ID
- A71_04GLC1915
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 25 Jun 2020
- 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 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Randomized, Open-label, Active Controlled, Phase 2 Trial, Proof Of Concept Study to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT04448223
- Acronym / sponsor ID
- A71_04GLC1915
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 5 Dec 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 25 Jun 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 evaluate efficacy and safety of CKD-351
Detailed description
Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-351 | Experimental | Drug: CKD-351CKD-351 |
| Latanoprost+Dorzolamide | Active comparator | Drug: Latanoprost+DorzolmamideLatanoprost(50ul/ml) Dorzolmamide(20mg/ml) |
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 who has primary open-angle glaucoma or ocular hypertension
- Subjects who sign on an informed consent form willingly
Key exclusion criteria (10 listed)
- Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
- Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
- Subjects who were diagnosed as below
- Subjects with ocular inflammation or infection within the last 3 months
- Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
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-351Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day | Drug | CKD-351 |
| Latanoprost+DorzolmamideLatanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day | Drug | Latanoprost+Dorzolamide |
Primary outcome
Change in mean intraocular pressure for efficacy measurement
Time frame: Baseline, 4 weeks
Change in mean intraocular pressure at 4 weeks compared to baseline
2 secondary outcomes
Change in mean intraocular pressure for efficacy measurement
Time frame: Baseline, 2 weeks
Changes in intraocular pressure for efficacy measurement
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
KiHo Park, MD principal investigator
Seoul 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 2 study testing CKD-351 and Latanoprost+Dorzolmamide in people with Primary Open Angle Glaucoma and Ocular Hypertension, 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 10 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 25 Jun 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KiHo Park (+82-10-3458-3172, kihopark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean intraocular pressure for efficacy measurement (time frame: Baseline, 4 weeks). 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 25 Jun 2020.