A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) 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

NCT00967811

Enrollment

Registered

2009-08-28

Start date

2009-08-31

Completion date

2010-05-31

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 evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Interventions

DRUGFormulation E1 of L-PPDS

Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

DRUGFormulation E2 of L-PPDS

Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects over 18 years of age diagnosed 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 * Subjects who have uncontrolled medical conditions * Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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