Status:
NOT_YET_RECRUITING
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Lead Sponsor:
University of Miami
Collaborating Sponsors:
AbbVie
Conditions:
Glaucoma
Open-Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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, indi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07217678
Start Date
January 31 2026
End Date
January 31 2028
Last Update
October 16 2025
Active Locations (1)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33134