Actively Recruiting
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Led by University of Miami · Updated on 2026-03-05
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether reducing the use of topical eye medications by injecting a sustained release capsule called Durysta can decrease inflammation on the surface of the eye. This inflammation is measured by levels of caspase-1, a biomarker related to eye surface damage. The study focuses on adults with open-angle glaucoma or suspected glaucoma who use topical ocular hypotensive medications. Participants will receive a one-time injection of Durysta, which contains bimatoprost 10 micrograms, directly into the eye. After the injection, participants will be followed for three months to observe changes. The study does not involve any placebo or comparison groups and is open-label with no masking. During the study, researchers will measure changes in caspase-1 mRNA expression at baseline, one month, and three months after the injection. They will also assess corneal sensitivity, ocular pain using a visual analog scale, and corneal staining scores with the National Eye Institute grading system at the same time points. Participant adherence to medication and eye health will be monitored throughout the study period, which lasts three months in total.
CONDITIONS
Brief Title
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eye with open-angle glaucoma or suspected of open-angle glaucoma
- Pseudophakic in eye of interest with Shafer grading 653
- No more than 3 daily applications of topical glaucoma medications for at least 6 months, including one nightly preserved prostaglandin analog
- Good adherence to medication regimen with less than or equal to 20% missed doses in the last month
- Last dose of medication administered within the past 24 hours
- Presence of punctate epithelial erosions in the cornea with National Eye Institute scale greater than 3
You will not qualify if you...
- Retinal disease such as wet age-related macular degeneration, proliferative diabetic retinopathy, or central retinal vein occlusion
- Use of topical or systemic immunosuppressor or immunomodulator drugs like steroids, cyclosporine, lifitegrast, or antihistamines
- Use of preservative-free hypotensive medications
- Any clinical contraindications to receiving intracameral bimatoprost implantation
- History of recurrent conjunctivitis including allergic or atopic conjunctivitis
- History of partial or full corneal transplant
- History of ophthalmic surgery involving intraocular or tarsus-involving oculoplastic procedures within the last 6 months
- History of subconjunctival glaucoma surgery such as trabeculectomy, aqueous shunt, or Xen implant within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive a one-time intracameral injection of Durysta (bimatoprost 10mcg).
Visits at baseline, 1 month, and 3 months post-injection
Trial Site Locations
Total: 1 location
1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33134
Actively Recruiting
Research Team
J
Javier Paredes, BA, MBA
M
Monica Arango, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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