Trial | NCT03106532  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Sovesudil ...

  • Study Participants

    119
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
Data collection (electronic case report forms), Data dictionary (MedDRA)
Study Started
Mar 06
2017
Primary Completion
May 02
2018
Study Completion
May 02
2018
Last Update
Oct 26
2018

Drug PHP-201 0.25% ophthalmic solution

3 drops daily, 28 days

  • Other names: PHP-201

Drug PHP-201 0.5% ophthalmic solution

3 drops daily, 28 days

  • Other names: PHP-201

Drug Placebo ophthalmic solution

3 drops daily, 28 days

  • Other names: PHP-201

PHP-201 0.25% ophthalmic solution Experimental

PHP-201 0.25% ophthalmic solution, TID

PHP-201 0.5% ophthalmic solution Experimental

PHP-201 0.5% ophthalmic solution, TID

Placebo ophthalmic solution Placebo Comparator

Placebo ophthalmic solution, TID

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
No Results Posted