Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00650702

Acronym

CORE

Enrollment

Registered

2008-04-02

Start date

2008-03-31

Completion date

2009-02-28

Last updated

2013-09-19

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

Conditions

Glaucoma, Ocular Hypertension

Keywords

glaucoma, ocular hypertension, IOP

Brief summary

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Interventions

DRUGLatanoprost-PPDS

Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 18 yrs with open-angle glaucoma or ocular hypertension * Subjects who have a best-corrected visual acuity of 20/100 or better.

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. * Subjects who have a history of chronic or recurrent inflammatory eye disease.

Design outcomes

Primary

Measure	Time frame
IOP change from baseline	12 Weeks

Countries

United States

Outcome results

None listed

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