Recruiting

Durysta

Sponsor:

University of Miami

Code:

NCT07217678

Conditions

Glaucoma

Open-Angle Glaucoma

Ocular Hypertension

Glaucoma Suspect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Durysta, Bimatoprost Intracameral Implant 10 µg

Study Details

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, indicated by levels of caspase-1, an inflammatory biomarker.

Conditions

Glaucoma

Open-Angle Glaucoma

Ocular Hypertension

Glaucoma Suspect

Study ID

NCT07217678

Start date

Feb 9, 2026

Status verified date

Mar, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Durysta

Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

Interventions

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 measure

  • Change in Caspase-1 mRNA Expression Following Durysta Injection [ Time Frame: Baseline, post-injection 1 month, post-injection 3 months ]

Central Contacts and Locations

Central contacts

Javier Paredes, BA, MBA

305-326-6387jxp2537@med.miami.edu

Monica Arango, BA

305-326-6351mrarango@med.miami.edu

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33134

Contacts

Javier Paredes, BA, MBA

305-326-6387jxp2537@med.miami.edu

Monica Arango, BA

305-326-6351mrarango@med.miami.edu

Principal Investigator:

Swarup S Swaminathan, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-05.