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

PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481077

Enrollment

Registered

2011-11-29

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2013-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension (OH)

Brief summary

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).

Interventions

DRUGLatanoprost-PPDS

Sustained release for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
IOP change from baseline	12 weeks to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026