A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01037036

Enrollment

Registered

2009-12-21

Start date

2009-12-31

Completion date

2010-07-31

Last updated

2014-01-10

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

Conditions

Ocular Hypertension, Open-Angle Glaucoma

Keywords

Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP

Brief summary

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Interventions

DRUGLatanoprost Punctal Plug Delivery System

To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.

DRUGXalatan

Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 18 years * Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension * Currently on prostaglandin therapy

Exclusion criteria

* Uncontrolled medical conditions * Subjects who wear contact lenses * Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Design outcomes

Primary

Measure	Time frame
Change from baseline in IOP measurements	4 weeks

Countries

United States

Outcome results

None listed

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