Primary Open Angle GlaucomaPhase 3NCT04863365
A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing PHP-201 ophthalmic solution in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by pH Pharma at 1 site in South Korea.
Trial summary
This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension. 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?
- PHP-201 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2021to Nov 2023
- 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
Subject Inclusion Criteria:
- The age of 19 years or older
- Diagnosis of open-angle glaucoma (POAG) or ocular hypertension (OH)
- Intraocular Pressure(IOP) ≤ 35mmHg at both eye and IOP ≥ 22mmHg at either eye
- Shaffer's grading > 2
- Best-corrected visual acuity in both eye equivalent to 0.2logMar
- Able and willing to give signed informed consent
Subject Exclusion Criteria:
- Central corneal thickness <500㎛ or >600㎛
- Medical history of following
- Closed-angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, narrow-angle glaucoma
- Advanced glaucomatous loss; mean deviation (MD) < -12dB
- Moderate to severe inflammatory/infectious disease in either eye
- Advanced retinopathy
- Surgical or laser therapy for glaucoma treatment
- Have confirmed the following at the screening visit
- SBP ≥ 180mmHg or DBP ≥ 110mmHg
- HbA1c > 9.0%
- CrCl < 30mL/min
- AST or ALT ≥ 3 X ULN
- Unstable angina, myocardial infarction, transient ischemic attack, cerebral stroke, coronary artery bypass graft, or coronary angioplasty within 24 weeks
- History of malignant tumor with 5 years
- History of the causative disease that may cause secondary glaucoma, including a history of steroid administration for more than 4 weeks
- Conditions need to wear contact lenses during the study
- Known hypersensitivity to any component of the investigational product
- Who has administered topical/systemic drugs that may affect the study within a certain period prior to eligibility check or are expected to need administration during the study duration
- Prostaglandin analogues: 5 weeks
- β-blockers: 4 weeks
- ROCK inhibitors: 4 weeks
- α/β-adrenergic agonists: 2 weeks
- Muscarinic agonists: 1 week
- Carbonic anhydrase inhibitors: 1 week
- Systemic corticosteroids: 4 weeks
- Pregnant or breast-feeding
- Who disagreed with the use of the methods of proper contraception during the study duration
- Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer
- Unsuitable for participation in the study according to the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hopsital
Seoul
KiHo Park, MD. PhD
KiHo Park, MD. PhD
About this study
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PHP-201 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
Read the detailed description
As a selective ROCK inhibitor, PHP-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Placebo ophthalmic solution, PHP-201 ophthalmic solution
- Keywords
- Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ophthalmic solutionDrug
Also called Matching placebo
A matching placebo ophthalmic solution, 3 drops daily, 28 days
PHP-201 ophthalmic solutionDrug
Also called Sovesudil
PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | A matching placebo ophthalmic solution, TID Receives: Drug: Placebo ophthalmic solution |
| PHP-201 treatment | Experimental | PHP-201 0.5% ophthalmic solution, TID Receives: Drug: PHP-201 ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Mean IOP change from baseline
Measured: 4 weeks
Secondary outcomes (1)
Diurnal intraocular pressure
Mean of diurnal IOP change from baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (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.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pH Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Younyoung Hwang, Study director, pH Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863365
- Sponsor's protocol ID
- PHP-201-S301
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 18 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PHP-201 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT04863365
- Acronym / sponsor ID
- PHP-201-S301
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- pH PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Apr 2021 (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.
This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
Detailed description
As a selective ROCK inhibitor, PHP-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment | Placebo comparator | Drug: Placebo ophthalmic solutionA matching placebo ophthalmic solution, TID |
| PHP-201 treatment | Experimental | Drug: PHP-201 ophthalmic solutionPHP-201 0.5% ophthalmic solution, TID |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Placebo ophthalmic solutionAlso: Matching placeboA matching placebo ophthalmic solution, 3 drops daily, 28 days | Drug | Placebo treatment |
| PHP-201 ophthalmic solutionAlso: SovesudilPHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days | Drug | PHP-201 treatment |
Primary outcome
Intraocular Pressure
Time frame: 4 weeks
Mean IOP change from baseline
1 secondary outcome
Diurnal intraocular pressure
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Younyoung Hwang study director
pH Pharma
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 PHP-201 ophthalmic solution in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by pH Pharma 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?
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 18 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. Some participants in this study may receive a placebo. 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 Younyoung Hwang (+82 31 779 5301, younyoung.hwang@ph-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 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 18 Jun 2021.