Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cyclosporine 0.010% · 1 trial · 1 indication
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is \>316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
| Arm | Type | Description |
|---|---|---|
| Cyclosporine Ophthalmic Solution (COS) followed by COS | EXPERIMENTAL | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
| Placebo followed by COS | OTHER | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. |
| Name | Type | Description |
|---|---|---|
| Cyclosporine Vehicle | DRUG | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. |
| Cyclosporine 0.010% | DRUG | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
Inclusion Criteria: * Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye) * Be on stable doses of your current AKC medications for at least 2 weeks Exclusion Criteria: * You have used contact lenses within 48 hours of Day 1 or think you may have t...