Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Phase 1

Completed

• Conditions: Ocular Hypertension
• Interventions: Drug: Subconjunctival injection of liposomal latanoprost

• Registration Number: NCT01987323
• Lead Sponsor: Singapore Eye Research Institute

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-10-30
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Study First Posted: 2013-11-19
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 -

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipolat	Subconjunctival injection of liposomal latanoprost	Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants

Primary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events	3 months

Secondary Outcome Measures

Name	Time	Method
intraocular pressure	3 months	Intraocular pressure reduction from baseline pressure reading