Evaluation of PHP-201 Ophthalmic Solution in Patients Wit... | NCT03106532

Studies
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma

NCT03106532

Sponsor

pH Pharma

Status

Completed

Last Update Posted

Oct 26, 2018Actual

Enrollment

119Actual

Phase

Phase 2

Conditions

Normal Tension Glaucoma

Interventions

PHP-201 0.25% ophthalmic solution
PHP-201 0.5% ophthalmic solution
Placebo ophthalmic solution

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2017Actual

Primary Completion Date

May 2, 2018Actual

Completion Date

May 2, 2018Actual

First Submitted Date

Mar 30, 2017

First Submission Date that Met QC Criteria

Apr 7, 2017

First Posted Date

Apr 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2018

Last Update Posted Date

Oct 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Data collection (electronic case report forms), Data dictionary (MedDRA)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PHP-201 0.25% ophthalmic solution	Experimental	PHP-201 0.25% ophthalmic solution, TID	Drug: PHP-201 0.25% ophthalmic solution
PHP-201 0.5% ophthalmic solution	Experimental	PHP-201 0.5% ophthalmic solution, TID	Drug: PHP-201 0.5% ophthalmic solution
Placebo ophthalmic solution	Placebo Comparator	Placebo ophthalmic solution, TID	Drug: Placebo ophthalmic solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PHP-201 0.25% ophthalmic solution	Drug	3 drops daily, 28 days	PHP-201 0.25% ophthalmic solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean diurnal IOP change	Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
The number of patient with adverse events	The number of patient with adverse events including ocular adverse events	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057066	Low Tension Glaucoma

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D009901	Optic Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723048	sovesudil
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided