Fuchs Endothelial Corneal Dystrophy
Conditions
Brief summary
This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
Interventions
DRUGSTN1010904 ophthalmic suspension 0.03% BID
0.03% STN1010904 ophthalmic suspension BID
DRUGSTN1010904 ophthalmic suspension 0.1% BID
0.1% STN1010904 ophthalmic suspension BID
DRUGPlacebo (Vehicle) BID
Placebo (vehicle) BID
Sponsors
Santen Inc.
ActualEyes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female diagnosed with FECD.
Exclusion criteria
* Females who are pregnant or lactating. * Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18 | The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score. | This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score. |
| Change From Baseline in BCVA With Contrast Level of 10% at Month 18 | The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score. | This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score. |
| Change From Baseline in Contrast Sensitivity With Glare Light at Month 18 | The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score. | This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value. AULCSF is calculated using the below steps: Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18. Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18). Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function. |
Countries
France, India, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 41 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment France | 5 participants |
| Region of Enrollment India | 4 participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 | 0 / 21 |
| other Total, other adverse events | 17 / 33 | 23 / 32 | 8 / 21 |
| serious Total, serious adverse events | 0 / 33 | 1 / 32 | 1 / 21 |
Outcome results
None listed