Recruiting NCT07217678
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Durysta, Bimatoprost Intracameral Implant 10 µg.
- Who it may be relevant to
- Registry conditions: Glaucoma, Open-Angle Glaucoma, Ocular Hypertension, Glaucoma Suspect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Durysta, Bimatoprost Intracameral Implant 10 µg
Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months.
Primary outcome measures
- Change in Caspase-1 mRNA Expression Following Durysta Injection [Time frame: Baseline, post-injection 1 month, post-injection 3 months]
Secondary outcome measures (3)
- Change in Corneal Sensitivity Following Durysta Injection [Time frame: Baseline, post-injection 1 month, post-injection 3 months]
- Change in Ocular Pain Symptoms via Visual Analog Scale (VAS) [Time frame: Baseline, post-injection 1 month, post-injection 3 months]
- Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System [Time frame: Baseline, post-injection 1 month, post-injection 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bascom Palmer Eye Institute — Miami
Identifiers
NCT: NCT07217678 · 20240111