Open Label Extension of LipoLat-CS202

November 18, 2020 updated by: Peregrine Ophthalmic

An Open-label Extension Study of the Safety and Efficacy of Subconjunctival Liposomal Latanoprost (POLAT-001) in Patients With Ocular Hypertension and Primary Open Angle Glaucoma

This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Goose Creek, South Carolina, United States, 29445
        • Professional Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were randomized to received POLAT-001 and successfully completed LipoLat-CS202

Description

  • Inclusion criteria

    1. Successful completion of 3 months of participation in Study LipoLat-CS202.
    2. Treatment with POLAT-001 in Study LipoLat-CS202.
    3. Able and willing to give signed informed consent and follow study instructions.
  • Exclusion criteria

Excluded from the study will be individuals with the following characteristics:

1. The development, during study LipoLat-CS202, of any exclusion criteria from that study (e.g., concomitant medication or co-morbid disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP)
Time Frame: 3 months
Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Ophthalmic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LipoLat-CS203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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