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

Normal Tension Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106532
• Other study ID #: PHP-201-S203
• Status: Completed
• Phase: Phase 2
• Start date: March 6, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: October 2018
• Source: pH Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma

Intervention

Drug:
• PHP-201 0.25% ophthalmic solution
3 drops daily, 28 days
• PHP-201 0.5% ophthalmic solution
3 drops daily, 28 days
• Placebo ophthalmic solution
3 drops daily, 28 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
pH Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal IOP change	Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks	4 weeks
Secondary	The number of patient with adverse events	The number of patient with adverse events including ocular adverse events	28 days