Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Singapore Eye Research Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Hypertension

Treatments: Drug: Subconjunctival injection of liposomal latanoprost

Study type: Interventional

Funder types: Other

Identifiers

NCT01987323

R967/76/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No 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

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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Lipolat

Experimental group

Description:

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

Treatment:

Drug: Subconjunctival injection of liposomal latanoprost