NCT05716945View on ClinicalTrials.gov

The OPTIMISE Study

PHASE4RecruitingINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

July 29, 2024

Primary Completion Date

September 30, 2028

Study Completion Date

March 31, 2029

Conditions
Pseudophakic Bullous KeratopathyFuchs' Endothelial DystrophyIntraocular Pressure
Interventions
DRUG

Fluorometholone 0.1% Oph Susp

"Year 1: DMS 0.1% 6 times a day for 1 month followed by FML 0.1% 4 times a day for two months tapered off to once daily within four months and then once a day for 6 months.~Year 2: Half the patients in each study arm will use FML 0.1% daily."

DRUG

Dexamethasone 0.1% ophthalmic suspension

Year 1: DMS 0.1% 6 times a day for 1 month tapered off to once daily within 6 months and then once a day for 6 months.

OTHER

Stop steroids

Half the patients in each study arm will discontinue steroids.

Trial Locations (8)

7300 DS

RECRUITING

Gelre Ziekenhuizen, Apeldoorn

6500 HB

RECRUITING

Radboud Universitair Medisch Centrum, Nijmegen

6202 AZ

RECRUITING

Maastricht Universitair Medisch Centrum+, Maastricht

1105 AZ

RECRUITING

Amsterdam Universitair Medisch Centrum, Amsterdam

7400 GC

RECRUITING

Deventer Ziekenhuis, Deventer

9700 RB

NOT_YET_RECRUITING

Universitair Medisch Centrum Groningen, Groningen

2333 ZA

RECRUITING

Leiden Universitair Medisch Centrum, Leiden

3584 CX

NOT_YET_RECRUITING

Universitair Medisch Centrum Utrecht, Utrecht

All Listed Sponsors
lead

Maastricht University Medical Center

OTHER