Back to results

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Primary Purpose

Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Subconjunctival injection of liposomal latanoprost

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring glaucoma, raised intraocular pressure

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Glaucoma patients who have eyes with raised IOP (baseline IOP >21 mmHg) due to end-stage glaucoma with a poor visual prognosis.

Exclusion criteria:

Active or recent eye infection, endophthalmitis
Known hypersensitivity to latanoprost
Only eye
Previous glaucoma filtration surgeries or trabeculectomy
Intraocular pressure less than 12mmHg.
Inability to give informed consent.
Inability to safely administer a subconjunctival injection
Uncontrolled systemic hypertension, CVA or TIA within the previous month.
Pregnancy -

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipolat

Arm Description

Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants

Outcomes

Primary Outcome Measures

Number of participants with serious adverse events

Secondary Outcome Measures

intraocular pressure

Intraocular pressure reduction from baseline pressure reading

Full Information

NCT ID

NCT01987323

First Posted

October 30, 2013

Last Updated

November 18, 2013

Sponsor

Singapore Eye Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01987323

Brief Title

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Official Title

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Singapore Eye Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of latanoprost in treating glaucoma. Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators hypothesize that this would be safe and efficacious in humans as well. Methodology: A pilot study to assess a liposome formulation containing latanoprost. The investigators will recruit 6 study subjects with eyes that have raised IOP, for subconjunctival injection of this liposome formulation. The recruited eye will be injected and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter. Importance: If proven safe, this method of drug delivery could potentially be used for treatment of raised intraocular pressures in blinding conditions such as glaucoma.

Detailed Description

The number of recorded adverse events and intolerance to the subconjunctival injection procedure by the participants during the study period was used as a measure of safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension

Keywords

glaucoma, raised intraocular pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lipolat

Arm Type

Experimental

Arm Description

Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants

Intervention Type

Drug

Intervention Name(s)

Subconjunctival injection of liposomal latanoprost

Primary Outcome Measure Information:

Title

Number of participants with serious adverse events

Time Frame

3 months

Secondary Outcome Measure Information:

Title

intraocular pressure

Description

Intraocular pressure reduction from baseline pressure reading

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Glaucoma patients who have eyes with raised IOP (baseline IOP >21 mmHg) due to end-stage glaucoma with a poor visual prognosis. Exclusion criteria: Active or recent eye infection, endophthalmitis Known hypersensitivity to latanoprost Only eye Previous glaucoma filtration surgeries or trabeculectomy Intraocular pressure less than 12mmHg. Inability to give informed consent. Inability to safely administer a subconjunctival injection Uncontrolled systemic hypertension, CVA or TIA within the previous month. Pregnancy -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina T Wong, MD, PhD

Organizational Affiliation

Singapore National Eye Centre

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

https://eservice.hsa.gov.sg/prism/ct_r/enquiry.do?action=getAllTherapeuticArea

Description

Related Info

Learn more about this trial

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

We'll reach out to this number within 24 hrs