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

A Phase 2 Study Evaluating Safety and Efficacy 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

NCT01229982

Enrollment

121

Registered

2010-10-28

Start date

2010-10-31

Completion date

2011-08-31

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

Ocular Hypertension, Open Angle Glaucoma

Brief summary

The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Interventions

DRUGLatanoprost-PPDS

Punctal Plug

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG. * Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion criteria

* Functionally significant vision loss, or progressive field loss within the last year. * Contact lens wear at any time during the treatment period. * Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®. * Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment. * Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim. * Currently on chronic ocular topical medications * Currently on any ophthalmic or systemic steroid therapy. * Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries. * History of macular edema * History of chronic/recurrent inflammatory eye disease. * History of a non-response to topical prostaglandin therapy. * Subjects who have epiphora.

Design outcomes

Primary

Measure	Time frame	Description
IOP change from baseline at 4 weeks	Baseline to 4 Weeks	4 Weeks minus baseline

Countries

Canada

Outcome results

None listed

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