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New treatment option for Pseudophakic Bullous Keratopathy
Official title The OPTIMISE Study
ClinicalTrials.gov ID: NCT05716945
What this study is testing
What is Fluorometholone 0.1% Oph Susp?
Fluorometholone 0.1% Oph Susp is an investigational medicine, given as an once-daily, being studied as a potential treatment for pseudophakic bullous keratopathy.
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
- Rationale: The cornea is the most transplanted tissue in the Netherlands, with more than 1,500 procedures performed each year. A minimally invasive technique called Descemet Membrane Endothelial Keratoplasty (DMEK) has become the preferred method in the past decade.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- \- Patients aged 21 years or older registered on the NOTR as candidates for DMEK corneal transplantation
You likely can't join if
- Inability to complete follow up or comply with study procedures
- The participant is vulnerable
- Previous corneal graft in the study eye
- Known sensitivity or contraindication to the ingredients in the study medications
- History of uveitis
- History of any herpes simplex infection
See the full eligibility criteria
- \- Patients aged 21 years or older registered on the NOTR as candidates for DMEK corneal transplantation
- Inability to complete follow up or comply with study procedures
- The participant is vulnerable
- Previous corneal graft in the study eye
- Known sensitivity or contraindication to the ingredients in the study medications
- History of uveitis
- History of any herpes simplex infection
- Human Leukocyte Antigen (HLA) typed allograft
- Pregnancy (current and planned) or lactation
- Use of other local or systemic immunosuppressive drugs
The study team makes the final eligibility decision.
Where it's taking place
- Apeldoorn, Gelderland, Netherlands
- Nijmegen, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Amsterdam, North Holland, Netherlands
- Deventer, Overijssel, Netherlands
- Groningen, Provincie Groningen, Netherlands
- Leiden, South Holland, Netherlands
- Utrecht, Utrecht, Netherlands
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 - 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Apeldoorn, Gelderland, Netherlands; Nijmegen, Gelderland, Netherlands; Maastricht, Limburg, Netherlands; Amsterdam, North Holland, Netherlands; Deventer, Overijssel, Netherlands; Groningen, Provincie Groningen, Netherlands and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.