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Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987323
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
A/Prof Tina Wong, Singapore Eye Research Institute

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.


Condition or disease Intervention/treatment Phase
Ocular Hypertension Drug: Subconjunctival injection of liposomal latanoprost Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: Lipolat
Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
Drug: Subconjunctival injection of liposomal latanoprost



Primary Outcome Measures :
  1. Number of participants with serious adverse events [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. intraocular pressure [ Time Frame: 3 months ]
    Intraocular pressure reduction from baseline pressure reading



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

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


Sponsors and Collaborators
Singapore Eye Research Institute
Investigators
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Principal Investigator: Tina T Wong, MD, PhD Singapore National Eye Centre
Additional Information:
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Responsible Party: A/Prof Tina Wong, Associate Professor, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT01987323    
Other Study ID Numbers: R967/76/2012
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by A/Prof Tina Wong, Singapore Eye Research Institute:
glaucoma
raised intraocular pressure
Additional relevant MeSH terms:
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Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents