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NCT02599688 Clinical Trial

Open Label Extension of LipoLat-CS202

Glaucoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02599688
Other study ID # LipoLat-CS203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date June 2016

Study information
Verified date November 2020
Source Peregrine Ophthalmic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility - 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation only
No intervention in this study.

Locations
Country Name City State
United States Professional Research Network Goose Creek South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Peregrine Ophthalmic

Country where clinical trial is conducted

United States, 

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