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

An Open-Label, Phase 2 Study 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

NCT00820300

Enrollment

113

Registered

2009-01-12

Start date

2009-01-31

Completion date

2009-12-31

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

Brief summary

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

Interventions

DRUGLatanoprost-PPDS

Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Subjects who wear contact lenses. * Uncontrolled medical conditions * 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	6 weeks

Countries

United States

Outcome results

None listed

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