A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of 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

NCT01481077

PPL GLAU 13

Details and patient eligibility

About

The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).

Enrollment: 77 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 medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 3 patient groups

Treatment A

Experimental group

Treatment:

Drug: Latanoprost-PPDS

Treatment B

Experimental group

Treatment:

Drug: Latanoprost-PPDS

Treatment C

Experimental group

Treatment:

Drug: Latanoprost-PPDS