NCT00845299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

February 16, 2009

Last Update Submit

September 16, 2013

Conditions

GlaucomaOcular Hypertension

Keywords

glaucomaocular hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP change from baseline

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride

Drug: Latanoprost punctal plugDrug: artificial tears preserved with Benzalkonium Chloride

2

EXPERIMENTAL

Latanoprost punctal plug only

Drug: Latanoprost punctal plug

Interventions

Latanoprost punctal plugDRUG

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

12
artificial tears preserved with Benzalkonium ChlorideDRUG
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Benzalkonium Compounds

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Benzylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Oscar Cuzzani, MD

    QLT Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

US(1)