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

pH Pharma

Status and phase: Completed; Phase 2

Conditions: Normal Tension Glaucoma

Treatments: Drug: PHP-201 0.25% ophthalmic solution; Drug: PHP-201 0.5% ophthalmic solution; Drug: Placebo ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03106532

PHP-201-S203

Details and patient eligibility

About

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

Full description

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

Enrollment: 119 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 3 patient groups, including a placebo group

PHP-201 0.25% ophthalmic solution

Experimental group

Description:

PHP-201 0.25% ophthalmic solution, TID

Treatment:

Drug: PHP-201 0.25% ophthalmic solution

PHP-201 0.5% ophthalmic solution

Experimental group

Description:

PHP-201 0.5% ophthalmic solution, TID

Treatment:

Drug: PHP-201 0.5% ophthalmic solution

Placebo ophthalmic solution

Placebo Comparator group

Description:

Placebo ophthalmic solution, TID

Treatment:

Drug: Placebo ophthalmic solution