Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

November 18, 2013 updated by: A/Prof Tina Wong, Singapore Eye Research Institute

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 1

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

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lipolat
Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
Drug: Subconjunctival injection of liposomal latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with serious adverse events
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure
Time Frame: 3 months
Intraocular pressure reduction from baseline pressure reading
3 months

Collaborators and Investigators

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

Sponsor

Singapore Eye Research Institute

Investigators

  • Principal Investigator: Tina T Wong, MD, PhD, Singapore National Eye Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (ESTIMATE)

November 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R967/76/2012

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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