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

Phase 2

Completed

• Conditions: Normal Tension Glaucoma
• Interventions: Drug: PHP-201 0.25% ophthalmic solution; Drug: PHP-201 0.5% ophthalmic solution; Drug: Placebo ophthalmic solution

• Registration Number: NCT03106532
• Lead Sponsor: pH Pharma

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)

Study Timeline

• Study Start: 2017-03-06
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-10
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHP-201 0.25% ophthalmic solution	PHP-201 0.25% ophthalmic solution	PHP-201 0.25% ophthalmic solution, TID
PHP-201 0.5% ophthalmic solution	PHP-201 0.5% ophthalmic solution	PHP-201 0.5% ophthalmic solution, TID
Placebo ophthalmic solution	Placebo ophthalmic solution	Placebo ophthalmic solution, TID

Primary Outcome Measures

Name	Time	Method
Mean diurnal IOP change	4 weeks	Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks

Secondary Outcome Measures

Name	Time	Method
The number of patient with adverse events	28 days	The number of patient with adverse events including ocular adverse events

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of