Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension
NCT ID: NCT01987323
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2013-01-31
2013-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lipolat
Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
Subconjunctival injection of liposomal latanoprost
Interventions
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Subconjunctival injection of liposomal latanoprost
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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 -
21 Years
80 Years
ALL
No
Sponsors
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Singapore Eye Research Institute
OTHER
Responsible Party
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A/Prof Tina Wong
Associate Professor
Principal Investigators
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Tina T Wong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Singapore National Eye Centre
Related Links
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Other Identifiers
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R967/76/2012
Identifier Type: -
Identifier Source: org_study_id