Ocular Hypertension
Conditions
Keywords
glaucoma, raised intraocular pressure
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.
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.
Interventions
DRUGSubconjunctival injection of liposomal latanoprost
Sponsors
Singapore Eye Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with serious adverse events | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraocular pressure | 3 months | Intraocular pressure reduction from baseline pressure reading |
Outcome results
None listed