Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Subconjunctival injection of liposomal latanoprost


Participation Criteria
=================
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 -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipolat<br>Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants | Drug: Subconjunctival injection of liposomal latanoprost<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious adverse events |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, raised intraocular pressure