Recruiting at 1 site Phase 4 Glaucoma

Glaucoma study: Durysta

Official title Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use

ClinicalTrials.gov ID: NCT07217678

What this study is testing

What is Durysta?

Durysta is an investigational intracameral implant being studied as a potential treatment for glaucoma. It is designed to release bimatoprost, a prostaglandin analog that increases fluid outflow from the eye to lower pressure.

Also referred to as bimatoprost.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is testing whether a new injection reduces eye irritation. It looks at a sign of inflammation in the eye.
Who it's for
You may be able to join if you have glaucoma or high eye pressure.
What's involved
You would get an injection in your eye. The team will check your eyes for signs of irritation.
Time commitment
The study involves visits to check your eye health over time.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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)
  • 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)

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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)
  • 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)
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Miami, Florida, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.