Glaucoma, Primary Open AnglePhase 2NCT03067415
Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily
A Phase 2 study testing D565H(Latanoprost 25㎍/㎖) and D565(Latanoprost 50㎍/㎖) in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle, Ocular Hypertension
- What is being tested?
- D565H(Latanoprost 25㎍/㎖) and D565(Latanoprost 50㎍/㎖)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2017to 30 Sep 2017
- 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 IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye
- Subjects with a maximum corrected visual acuity of less or than 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 23Show 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 or more)
- 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
- Glaucoma surgery
- 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 6 months
- Subjects who wore need to wear contact lenses during the study
- Subjects who have drug interaction with the investigational product, have a significant effect on the intraocular pressure, or who may have an effect on the clinical trial results
- Subjects with known hypersensitivity to investigational product
- Women who are nursing, pregnant or planning pregnancy during the study
- Subjects with bronchial asthma or history
- Subjects who have received any other investigational product within 1 month prior to the first dosing
- Impossible subjects who participate in clinical trial by investigator's decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hosipital
Seoul, Jongno
KiHo Park, MD
About this study
Official title: A Multi Center, Randomized, Double-blind, Parallel Design, Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.
Read the detailed description
A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily in primary open angle glaucoma or ocular hypertension patients.
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Being tested
- D565H(Latanoprost 25㎍/㎖), D565(Latanoprost 50㎍/㎖)
- Keywords
- Glaucoma, Primary Open Angle, 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.
D565H(Latanoprost 25㎍/㎖)Drug
Also called Arm A
D565H twice daily
D565(Latanoprost 50㎍/㎖)Drug
Also called Arm B
D565 once daily
| Study group | Role | What they receive |
|---|---|---|
| D565H(Latanoprost 25㎍/㎖) | Experimental | D565H(Latanoprost 25㎍/㎖) Receives: Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖) |
| D565(Latanoprost 50㎍/㎖) | Active comparator | D565(Latanoprost 50㎍/㎖) Receives: Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean intraocular pressure at 4 weeks compared to baseline
Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Change in mean intraocular pressure at 2 weeks compared to baseline
Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks
Measured: Baseline, 2 weeks
Changes in intraocular pressure by measurement time
IOP variation by measurement time
Measured: 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 posted1 Mar 2017
- Study start30 Mar 2017
- Primary completion10 Sep 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies 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
- Model description
- Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 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
- NCT03067415
- Sponsor's protocol ID
- 171GLC16020
- Status last verified
- Feb 2017
- First submitted
- 24 Feb 2017
- Last updated
- 21 Jul 2017
- 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 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Double-blind, Parallel Design, Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
- ClinicalTrials.gov ID
- NCT03067415
- Acronym / sponsor ID
- 171GLC16020
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Keywords
- Glaucoma, Primary Open Angle, Ocular hypertension, CKD-351
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 10 Sep 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 1 Mar 2017 (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.
Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.
Detailed description
A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily 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
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| D565H(Latanoprost 25㎍/㎖) | Experimental | Drug: D565H(Latanoprost 25㎍/㎖), Drug: D565(Latanoprost 50㎍/㎖)D565H(Latanoprost 25㎍/㎖) |
| D565(Latanoprost 50㎍/㎖) | Active comparator | Drug: D565H(Latanoprost 25㎍/㎖), Drug: D565(Latanoprost 50㎍/㎖)D565(Latanoprost 50㎍/㎖) |
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 (23 listed)
- Subjects with IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye
- Subjects with a maximum corrected visual acuity of less or than 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 or more)
- 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 |
|---|---|---|
| D565H(Latanoprost 25㎍/㎖)Also: Arm AD565H twice daily | Drug | D565(Latanoprost 50㎍/㎖), D565H(Latanoprost 25㎍/㎖) |
| D565(Latanoprost 50㎍/㎖)Also: Arm BD565 once daily | Drug | D565(Latanoprost 50㎍/㎖), D565H(Latanoprost 25㎍/㎖) |
Primary outcome
Change in mean intraocular pressure at 4 weeks compared to baseline
Time frame: Baseline, 4 weeks
Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks
2 secondary outcomes
Change in mean intraocular pressure at 2 weeks compared to baseline
Time frame: Baseline, 2 weeks
Changes in intraocular pressure by measurement time
Time frame: 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 21 Jul 2017.
- 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 2 study testing D565H(Latanoprost 25㎍/㎖) and D565(Latanoprost 50㎍/㎖) in people with Glaucoma, Primary Open Angle 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 23 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 21 Jul 2017. 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 at 4 weeks compared to baseline (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 21 Jul 2017.