RECRUITINGPhase 4INTERVENTIONAL
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (1)
Bascom Palmer Eye Institute
Miami, Florida, United States