Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension
1 other identifier
interventional
6
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2013
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedNovember 19, 2013
November 1, 2013
5 months
October 30, 2013
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with serious adverse events
3 months
Secondary Outcomes (1)
intraocular pressure
3 months
Study Arms (1)
Lipolat
EXPERIMENTALSubconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
Interventions
Eligibility Criteria
You may qualify if:
- Glaucoma patients who have eyes with raised IOP (baseline IOP \>21 mmHg) due to end-stage glaucoma with a poor visual prognosis.
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tina T Wong, MD, PhD
Singapore National Eye Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 19, 2013
Study Start
January 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11