Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987323
• Other study ID #: R967/76/2012
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 30, 2013
• Last updated: November 18, 2013
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Singapore Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Subconjunctival injection of liposomal latanoprost

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with serious adverse events		3 months	Yes
Secondary	intraocular pressure	Intraocular pressure reduction from baseline pressure reading	3 months	No

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