A Phase 2 interventional study of STN1010904 ophthalmic suspension 0.03% BID and STN1010904 ophthalmic suspension 0.1% BID in Fuchs Endothelial Corneal Dystrophy, sponsored by Santen Inc.. Completed at 15 sites in 3 countries. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Santen Inc. (part of Santen Pharmaceutical Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's enrollment of 86 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Santen Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
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Exclusion Criteria:
Drug: STN1010904 ophthalmic suspension 0.03% BID
Drug: STN1010904 ophthalmic suspension 0.1% BID
Drug: Placebo (Vehicle) BID
0.03% STN1010904 ophthalmic suspension BID
0.1% STN1010904 ophthalmic suspension BID
Placebo (vehicle) BID
Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.
| Milestone | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID |
|---|---|---|---|
| Started | 32 | 32 | 22 |
| Completed | 22 | 22 | 19 |
| Not completed | 10 | 10 | 3 |
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.
| LogMAR | Placebo Vehicle BID | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID |
|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18 | 0.026 ± 0.0203 | 0.039 ± 0.0176 | 0.042 ± 0.0181 |
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.
| LogMAR | Placebo Vehicle BID | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID |
|---|---|---|---|
| Change From Baseline in BCVA With Contrast Level of 10% at Month 18 | -0.014 ± 0.0336 | -0.005 ± 0.0294 | 0.085 ± 0.0302 |
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.
| log CS × log(cpd) | Placebo Vehicle BID | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID |
|---|---|---|---|
| Change From Baseline in Contrast Sensitivity With Glare Light at Month 18 | 0.060 ± 0.0479 | 0.078 ± 0.0420 | -0.067 ± 0.0434 |
Collected over Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| STN1010904 Ophthalmic Suspension 0.03% BID | 0/33 (0%) | 0/33 (0%) | 17/33 (51.5%) |
| STN1010904 Ophthalmic Suspension 0.1% BID | 0/32 (0%) | 1/32 (3.1%) | 23/32 (71.9%) |
| Placebo Vehicle BID | 0/21 (0%) | 1/21 (4.8%) | 8/21 (38.1%) |
| Event | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID |
|---|---|---|---|
| AmnesiaNervous system disorders | 0/33 | 0/32 | 1/21 |
| EpilepsyNervous system disorders | 0/33 | 0/32 | 1/21 |
| Atrial fibrillationCardiac disorders | 0/33 | 1/32 | 0/21 |
| PericarditisCardiac disorders | 0/33 | 1/32 | 0/21 |
| Event | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID |
|---|---|---|---|
| Corneal oedemaEye disorders | 5/33 | 6/32 | 1/21 |
| Eye irritationEye disorders | 4/33 | 1/32 | 1/21 |
| Vision blurredEye disorders | 3/33 | 2/32 | 1/21 |
| Eye painEye disorders | 3/33 | 1/32 | 0/21 |
| Foreign body sensation in eyesEye disorders | 1/33 | 2/32 | 0/21 |
| Urinary tract infectionInfections and infestations | 1/33 | 2/32 | 0/21 |
| ConjunctivitisInfections and infestations | 0/33 | 2/32 | 0/21 |
| ErythemaSkin and subcutaneous tissue disorders | 0/33 | 2/32 | 0/21 |
| PhotophobiaEye disorders | 2/33 | 0/32 | 0/21 |
| COVID-19Infections and infestations | 2/33 | 0/32 | 0/21 |
| Age, Categorical(Participants) | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 15 | 10 | 45 |
| >=65 years | 12 | 17 | 12 | 41 |
| Age, Continuous(years) | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID | Total |
|---|---|---|---|---|
| Mean | 60.8 ± 10.96 | 64.0 ± 7.88 | 62.9 ± 9.73 | 62.5 ± 9.58 |
| Sex: Female, Male(Participants) | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID | Total |
|---|---|---|---|---|
| Female | 21 | 22 | 15 | 58 |
| Male | 11 | 10 | 7 | 28 |
| Race (NIH/OMB)(Participants) | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 5 | 6 | 4 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 1 | 3 |
| White | 19 | 21 | 13 | 53 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 5 | 4 | 15 |
| Region of Enrollment(participants) | STN1010904 Ophthalmic Suspension 0.03% BID | STN1010904 Ophthalmic Suspension 0.1% BID | Placebo Vehicle BID | Total |
|---|---|---|---|---|
| United States | 22 | 21 | 14 | 57 |
| France | 6 | 5 | 4 | 15 |
| India | 4 | 6 | 4 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →