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NCT03106532 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
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