NCT02599688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

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

November 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

December 14, 2020

Completed
Last Updated

December 14, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

November 5, 2015

Results QC Date

September 8, 2020

Last Update Submit

November 18, 2020

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Observation onlyOTHER

No intervention in this study.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professional Research Network

Goose Creek, South Carolina, 29445, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Chief Operating Officer
Organization
Peregrine Ophthalmic Pte Ltd
jchua@peregrineop.com
65 97914382

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 6, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 14, 2020

Results First Posted

December 14, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)