A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension (OH); Glaucoma

Treatments: Drug: Latanoprost-PPDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01481051

PPL GLAU 12

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female at least 18 years old
• Diagnosis of bilateral open angle glaucoma or ocular hypertension
• Unmedicated IOP must be ≥22mm Hg

Exclusion criteria

• Any significant vision loss in the last year
• No contact lens use for the length of the study
• Abnormal eye lids, eye infection, or diseases to the eye
• Recent eye surgery
• Uncontrolled medication conditions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)