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Completed

NCT Number: NCT01987323

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Subconjunctival injection of liposomal latanoprost

Drug

Primary outcomes

  1. Number of participants with serious adverse events

    Time frame: 3 months

Secondary outcomes

  1. intraocular pressure

    Time frame: 3 months

    Intraocular pressure reduction from baseline pressure reading

Sponsors and collaborators

Lead sponsor

Singapore Eye Research Institute

Other

Registry information

Official study title

Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 19, 2013
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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