Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension
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|ClinicalTrials.gov Identifier: NCT01987323|
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension||Drug: Subconjunctival injection of liposomal latanoprost||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
Drug: Subconjunctival injection of liposomal latanoprost
- Number of participants with serious adverse events [ Time Frame: 3 months ]
- intraocular pressure [ Time Frame: 3 months ]Intraocular pressure reduction from baseline pressure reading
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987323
|Principal Investigator:||Tina T Wong, MD, PhD||Singapore National Eye Centre|