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

NCT03106532 — Phase 2, Completed, 119 participants, pH Pharma

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03106532
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	119 (Actual)
Sponsor	pH Pharma (Industry)
Conditions	Normal Tension Glaucoma
Interventions	PHP-201 0.25% ophthalmic solution, PHP-201 0.5% ophthalmic solution, Placebo ophthalmic solution (Drug)
Dates	start 2017-03-06, primary completion 2018-05-02, completion 2018-05-02, first posted 2017-04-10, last updated 2018-10-26
Locations	1 site in South Korea

-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

Expand all sections · Collapse all

+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
PHP-201 0.25% ophthalmic solution	Experimental	Drug: PHP-201 0.25% ophthalmic solution	PHP-201 0.25% ophthalmic solution, TID
PHP-201 0.5% ophthalmic solution	Experimental	Drug: PHP-201 0.5% ophthalmic solution	PHP-201 0.5% ophthalmic solution, TID
Placebo ophthalmic solution	Placebo comparator	Drug: Placebo ophthalmic solution	Placebo ophthalmic solution, TID

PHP-201 0.25% ophthalmic solution (Drug), also known as PHP-201: 3 drops daily, 28 days
PHP-201 0.5% ophthalmic solution (Drug), also known as PHP-201: 3 drops daily, 28 days
Placebo ophthalmic solution (Drug), also known as PHP-201: 3 drops daily, 28 days

+Outcome measures

Primary outcomes

Mean diurnal IOP change [4 weeks]: Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks

Secondary outcomes

The number of patient with adverse events [28 days]: The number of patient with adverse events including ocular adverse events

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

My Notes

Public

To Read Reading Read