Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Recruiting · NCT07217678 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Durysta, Bimatoprost Intracameral Implant 10 µg
What this trial is about
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Eye with open-angle glaucoma or suspected of open-angle glaucoma
- Pseudophakic in eye of interest with Shafer grading ≥3
- ≤ 3 daily applications of topical glaucoma medications for ≥6 months (of which one is a nightly preserved PGA)
- Good adherence to medication regimen - screening questions to be asked of potential subject:
- In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%)
- When was the last administration? (Last dose must have been within last 24 hours)
- Presence of punctate epithelial erosions in the cornea (NEI scale \> 3)
Exclusion criteria
- Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion)
- Use of topical or systemic immunosuppressor or immunomodulator drug (e.g., steroids, cyclosporine, lifitegrast, or antihistamines)
- Use of preservative-free hypotensive medications
- Any clinical contraindications to receiving intracameral bimatoprost implantation
- History of recurrent conjunctivitis (e.g., allergic or atopic conjunctivitis)
- History of partial or full corneal transplant
- History of ophthalmic surgery (intraocular or tarsus-involving oculoplastic procedures) within last 6 months
- History of subconjunctival glaucoma surgery (i.e., trabeculectomy, aqueous shunt, Xen implant) within last 6 months
Where it is running
1 location listed across 1 US state.
- Bascom Palmer Eye Institute - Miami, Florida, United States