NCT00821002

Brief Summary

The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

January 8, 2009

Last Update Submit

September 16, 2013

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure change from baseline (mmHg)

    6 weeks

Secondary Outcomes (1)

  • Number of subjects with adverse events

    6 weeks

Study Arms (1)

Plug placement

EXPERIMENTAL
Drug: Latanoprost

Interventions

LatanoprostDRUG

Comparison of punctal plug placement between upper and lower puncta

Plug placement

Eligibility Criteria

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

You may qualify if:

  • Over 18 years
  • Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

You may not qualify if:

  • Uncontrolled medical conditions
  • Subjects who wear contact lenses
  • 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

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Oscar Cuzanni, MD, MSc

    QLT Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 12, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

US(1)