| Primary | Central Corneal Endothelial Cell Density (ECD) at Week 12 | Change in Central ECD at week 12 | | Posted | | Mean | Standard Deviation | cells/mm2 | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000530.86± 312.453
- OG001468.02± 322.361
- OG002228.05± 297.860
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Other (Wilcoxon Rank Sum Test) | | 0.0065 | | | | | | | | | | | | | | Superiority | | | | | Other (Wilcoxon Rank Sum Test) | | 0.0344 | |
|
| Secondary | Central Corneal ECD From Baseline to Each Subsequent Visit | | The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:
- Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.
- Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.
| Posted | | Mean | Standard Deviation | cells/mm2 | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Change From Baseline in Central Corneal Thickness | | The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:
- Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.
- Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.
| Posted | | Mean | Standard Deviation | μm | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Time to Achievement of no Corneal Oedema of Study Eye | | Proportions of patients from the FAS who achieved no corneal edema of the study eye | Posted | | Median | 95% Confidence Interval | Days | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit | | The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:
- Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.
- Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.
| Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Time to Achieve Central Corneal ECD 700 Cells/mm2 or More | | | Posted | | Median | 95% Confidence Interval | Days | | Up to 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness | | The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:
- Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.
- Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.
| Posted | | Count of Participants | | Participants | | Baseline up to 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit | | | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness | | | Posted | | Median | 95% Confidence Interval | Days | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |
| Secondary | Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit | | The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:
- Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.
- Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.
| Posted | | Mean | Standard Deviation | Percent | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | K-321 QID | K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night). | | OG001 | K-321 BID | K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321) | | OG002 | Placebo | Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night) |
| |