Normal Tension GlaucomaPhase 2NCT03106532
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
A Phase 2 study testing PHP-201 0.25% ophthalmic solution and PHP-201 0.5% ophthalmic solution in people with Normal Tension Glaucoma, run by pH Pharma at 1 site in South Korea.
Trial summary
Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Normal Tension Glaucoma
- What is being tested?
- PHP-201 0.25% ophthalmic solution and PHP-201 0.5% ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2017to 2 May 2018
- 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
- 19 years and older, female and male
- IOP ≤21 mmHg
- Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects
- BCVA ≥+0.2
Who cannot join
- Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)
- Subject who can't discontinue contact lenses
- Subject who can't discontinue topical/systemic IOP lowering medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma
Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma
Read the detailed description
Data collection (electronic case report forms), Data dictionary (MedDRA)
- Conditions
- Normal Tension Glaucoma
- Being tested
- PHP-201 0.25% ophthalmic solution, PHP-201 0.5% ophthalmic solution, Placebo ophthalmic solution
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHP-201 0.25% ophthalmic solutionDrug
Also called PHP-201
3 drops daily, 28 days
PHP-201 0.5% ophthalmic solutionDrug
Also called PHP-201
3 drops daily, 28 days
Placebo ophthalmic solutionDrug
Also called PHP-201
3 drops daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| PHP-201 0.25% ophthalmic solution | Experimental | PHP-201 0.25% ophthalmic solution, TID Receives: Drug: PHP-201 0.25% ophthalmic solution |
| PHP-201 0.5% ophthalmic solution | Experimental | PHP-201 0.5% ophthalmic solution, TID Receives: Drug: PHP-201 0.5% ophthalmic solution |
| Placebo ophthalmic solution | Placebo comparator | Placebo ophthalmic solution, TID Receives: Drug: Placebo ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal IOP change
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
The number of patient with adverse events
The number of patient with adverse events including ocular adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start6 Mar 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- pH Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106532
- Sponsor's protocol ID
- PHP-201-S203
- Status last verified
- Oct 2018
- First submitted
- 30 Mar 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT03106532
- Acronym / sponsor ID
- PHP-201-S203
- Conditions
- Normal Tension Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- pH PharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 10 Apr 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.
Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma
Detailed description
Data collection (electronic case report forms), Data dictionary (MedDRA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PHP-201 0.25% ophthalmic solution | Experimental | Drug: PHP-201 0.25% ophthalmic solutionPHP-201 0.25% ophthalmic solution, TID |
| PHP-201 0.5% ophthalmic solution | Experimental | Drug: PHP-201 0.5% ophthalmic solutionPHP-201 0.5% ophthalmic solution, TID |
| Placebo ophthalmic solution | Placebo comparator | Drug: Placebo ophthalmic solutionPlacebo ophthalmic solution, TID |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years and older, female and male
- IOP ≤21 mmHg
- Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects
- BCVA ≥+0.2
Key exclusion criteria (3 listed)
- Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)
- Subject who can't discontinue contact lenses
- Subject who can't discontinue topical/systemic IOP lowering medication
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 |
|---|---|---|
| PHP-201 0.25% ophthalmic solutionAlso: PHP-2013 drops daily, 28 days | Drug | PHP-201 0.25% ophthalmic solution |
| PHP-201 0.5% ophthalmic solutionAlso: PHP-2013 drops daily, 28 days | Drug | PHP-201 0.5% ophthalmic solution |
| Placebo ophthalmic solutionAlso: PHP-2013 drops daily, 28 days | Drug | Placebo ophthalmic solution |
Primary outcome
Mean diurnal IOP change
Time frame: 4 weeks
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
1 secondary outcome
The number of patient with adverse events
Time frame: 28 days
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 26 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Normal Tension Glaucoma
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Active, not recruitingPhase 2
Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
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Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PHP-201 0.25% ophthalmic solution and PHP-201 0.5% ophthalmic solution in people with Normal Tension Glaucoma, 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?
The sponsor lists 4 inclusion and 3 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 26 Oct 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. 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 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?
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?
Mean diurnal IOP change (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 26 Oct 2018.