ClinicalTrials.gg
CompletedNCT01481051Updated Sep 26, 2013

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

A Phase 2 interventional study of Latanoprost-PPDS in Glaucoma and Ocular Hypertension (OH), sponsored by Mati Therapeutics Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-26.

Sponsored by Mati Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

02

Conditions studied

  • Glaucoma
  • Ocular Hypertension (OH)
03

In context

Glaucoma

1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.

This study's enrollment of 57 is below the median of 65 across 1,296 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Mati Therapeutics Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female at least 18 years old
  • Diagnosis of bilateral open angle glaucoma or ocular hypertension
  • Unmedicated IOP must be ≥22mm Hg

Exclusion criteria

Exclusion Criteria:

  • Any significant vision loss in the last year
  • No contact lens use for the length of the study
  • Abnormal eye lids, eye infection, or diseases to the eye
  • Recent eye surgery
  • Uncontrolled medication conditions
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. IOP change from baseline

    Time frame: 12 weeks to baseline

07

Study locations

6 sites
  • Sall Research Medical Center, Inc
    Artesia, California 90701, United States
  • Wolstan & Goldberg Eye Associates
    Los Angeles, California 90505, United States
  • West Coast Eye Care Associates
    San Diego, California 92115, United States
  • Coastal Research Associates, LLC
    Roswell, Georgia 30076, United States
  • R and R Eye Associates
    San Antonio, Texas 78229, United States
  • Rocky Mountain Eye Care Associates
    Salt Lake City, Utah 84107, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2011
First posted
Nov 29, 2011
Start
Nov 2011
Primary completionActual
Sep 2012
CompletionActual
Sep 2012
Results delay requested
Sep 16, 2013
Last update
Sep 26, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01481051
Lead sponsor
Mati Therapeutics Inc.
Responsible party
Sponsor
First posted
Nov 29, 2011
Start date
Nov 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Sep 26, 2013

Study contacts

Suzanne Cadden
study director · QLT Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Latanoprost

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