Open Label Extension of LipoLat-CS202

An observational study of Glaucoma, run by Peregrine Ophthalmic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Glaucoma
What is being tested?: Observation only
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Jun 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Professional Research Network
Goose Creek, South Carolina, 29445

Other trials in United States

About this study

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

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

Conditions: Glaucoma
Being tested: Observation only
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observation onlyOther
No intervention in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Jun 2016

First posted6 Nov 2015 (estimated)
Study startNov 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02599688
Sponsor's protocol ID: LipoLat-CS203
Status last verified: Nov 2020
First submitted: 5 Nov 2015
Last updated: 14 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02599688
Acronym / sponsor ID: LipoLat-CS203
Conditions: Glaucoma
Study type: Observational
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Peregrine OphthalmicIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 6 Nov 2015 (estimated)
Results: Posted 14 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who were randomized to received POLAT-001 and successfully completed LipoLat-CS202

Key inclusion criteria (3 listed)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Observation onlyNo intervention in this study.	Other	–

Primary outcome

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).

Results and safety

Results posted to the registry on 14 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post Treatment Follow-up	18	14

Primary outcome: Intraocular Pressure (IOP)

Time frame: 3 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Post Treatment Follow-up n = 16
Value	-4.2 (4.0)

Population analysed: Per protocol

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Post Treatment Follow-up	0 of 18 (0%)	16 of 18 (88.9%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Recruiting
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Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Peregrine Ophthalmic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (IOP) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.