Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
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)
In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Durysta, Bimatoprost Intracameral Implant 10 µg
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1Bascom Palmer Eye Institute33134, MiamiFlorida, United States
Sponsors and collaborators
University of Miami
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov