Overview

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Status:
Completed

Trial end date:
2013-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Singapore Eye Research Institute

Treatments:

Latanoprost

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:

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 -