Fuchs Endothelial Corneal Dystrophy (FECD)
Conditions
Brief summary
Primary Efficacy Endpoints: - Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 - Change from baseline in BCVA with contrast level of 10% at Month 18 - Change from baseline in contrast sensitivity with glare light at Month 18, Safety Endpoint: - Safety of DE-109D will be assessed by adverse events (AEs), slit-lamp biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), and laboratory tests (serum chemistry, hematology, and urinalysis).
Detailed description
Secondary Efficacy Endpoints: - Best corrected visual acuity (BCVA) with contrast level of 100% at all postbaseline visits - BCVA with contrast level of 10% at all post-baseline visits - Contrast sensitivity with glare light at all post-baseline visits - Contrast sensitivity without glare light at all post-baseline visits., - Change and percent change from baseline in BCVA with contrast level of 100% at all post-baseline visits - Change and percent change from baseline in BCVA with contrast level of 10% at all post-baseline visits - Change and percent change from baseline in contrast sensitivity with glare light at all post-baseline visits, - Change and percent change from baseline in contrast sensitivity without glare light at all post-baseline visits - Change and percent change from baseline in central corneal thickness at all post-baseline visits. - Change and percent change from baseline in endothelial cell density at all post-baseline visits., - Change and percent change in Guttae formation (Modified Krachmer scale) at all post-baseline visits
Interventions
DRUGSTN1010904
Sponsors
Santen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoints: - Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 - Change from baseline in BCVA with contrast level of 10% at Month 18 - Change from baseline in contrast sensitivity with glare light at Month 18, Safety Endpoint: - Safety of DE-109D will be assessed by adverse events (AEs), slit-lamp biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), and laboratory tests (serum chemistry, hematology, and urinalysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: - Best corrected visual acuity (BCVA) with contrast level of 100% at all postbaseline visits - BCVA with contrast level of 10% at all post-baseline visits - Contrast sensitivity with glare light at all post-baseline visits - Contrast sensitivity without glare light at all post-baseline visits., - Change and percent change from baseline in BCVA with contrast level of 100% at all post-baseline visits - Change and percent change from baseline in BCVA with contrast level of 10% at all post-baseline visits - Change and percent change from baseline in contrast sensitivity with glare light at all post-baseline visits, - Change and percent change from baseline in contrast sensitivity without glare light at all post-baseline visits - Change and percent change from baseline in central corneal thickness at all post-baseline visits. - Change and percent change from baseline in endothelial cell density at all post-baseline visits., - Change and percent change in Guttae | — |
Countries
France
Outcome results
None listed