Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to 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

NCT00845299

Enrollment

Registered

2009-02-18

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

Keywords

glaucoma, ocular hypertension

Brief summary

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Interventions

DRUGLatanoprost punctal plug

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

DRUGartificial tears preserved with Benzalkonium Chloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 18 years 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 with a known sensitivity to latanoprost, BAK, or any other products required for the study * Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

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