Primary Open-angle GlaucomaPhase 3NCT03762369
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
A Phase 3 study testing CKD-351, Latanoprost and D930 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, Latanoprost and D930
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2018to 30 May 2022
- 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 who has primary Open-Angle Glaucoma or Ocular Hypertension
- Subjects who sign on an informed consent form willingly
Who cannot join
- Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
- Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
- Subjects who were diagnosed as below with monocular or both eye
- Acute or Chronic Closed-Angle Glaucoma
- Secondary Glaucoma
- Pseudoexfoliation Glaucoma
Show all 21Show fewer
- Neovascular Glaucoma
- Aphakia
- Phacocyst capsular torn intraocular lens
- Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
- Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
- Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
- Subjects who have medical history following
- Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
- Subjects who received topical or systemic steroids within the last 1 months
- Subjects who wore need to wear contact lenses during the study
- Women who are nursing, pregnant or planning pregnancy during the study
- Subjects with bronchial asthma or history
- Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis
- Subjects who have received any other investigational product within 1 month prior to randomization
- 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: Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial 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, Double-blind, Active controlled, Parallel design, Phase 3 trial 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, D930, Placebo of CKD-351, Placebo of D930
- 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
Also called Latanoprost+D930
twice a day
LatanoprostDrug
once a day
D930Drug
three times a day
Placebo of CKD-351Drug
once a day
Placebo of CKD-351Drug
twice a day
Placebo of D930Drug
three times a day
| Study group | Role | What they receive |
|---|---|---|
| CKD-351 | Experimental | Latanoprost+D930 Receives: Drug: CKD-351; Drug: D930 |
| Latanoprost | Active comparator | Not described Receives: Drug: Latanoprost; Drug: Placebo of CKD-351; Drug: Placebo of D930 |
| D930 | Active comparator | Not described Receives: Drug: D930; Drug: Placebo of CKD-351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean intraocular pressure at 12 weeks compared to baseline
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
Measured: Baseline, 4 weeks, 8 weeks
Changes in intraocular pressure by measurement time
IOP variation by measurement time
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start7 Dec 2018 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion30 May 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KiHo Park, Principal investigator, Seoul National University Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762369
- Sponsor's protocol ID
- 171GLC18006
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 3 Dec 2018
- 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 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT03762369
- Acronym / sponsor ID
- 171GLC18006
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2018 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 3 Dec 2018 (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, Double-blind, Active controlled, Parallel design, Phase 3 trial 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD-351 | Experimental | Drug: CKD-351, Drug: D930Latanoprost+D930 |
| Latanoprost | Active comparator | Drug: Latanoprost, Drug: Placebo of CKD-351, Drug: Placebo of D930 |
| D930 | Active comparator | Drug: D930, Drug: Placebo of CKD-351 |
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 (21 listed)
- Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
- Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
- Subjects who were diagnosed as below with monocular or both eye
- Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
- Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
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-351Also: Latanoprost+D930twice a day | Drug | CKD-351 |
| Latanoprostonce a day | Drug | Latanoprost |
| D930three times a day | Drug | CKD-351, D930 |
| Placebo of CKD-351once a day | Drug | Latanoprost |
| Placebo of CKD-351twice a day | Drug | D930 |
| Placebo of D930three times a day | Drug | Latanoprost |
Primary outcome
Change in mean intraocular pressure at 12 weeks compared to baseline
Time frame: Baseline, 12 weeks
2 secondary outcomes
Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks
Changes in intraocular pressure by measurement time
Time frame: 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- 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 principal investigator
Seoul National University Hosipital
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-351, Latanoprost and D930 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 21 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 3 Dec 2018. 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 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 at 12 weeks compared to baseline (time frame: Baseline, 12 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 3 Dec 2018.