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Also known as Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye · 1 trial · 1 indication
Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.
| Arm | Type | Description |
|---|---|---|
| Cyclosporine 0.010% eye drops | EXPERIMENTAL | Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Cyclosporine 0.005% eye drops | EXPERIMENTAL | Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Placebo (Vehicle for Cyclosporine) | PLACEBO_COMPARATOR | Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Name | Type | Description |
|---|---|---|
| Cyclosporine 0.010% eye drops | DRUG | Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Cyclosporine 0.005% eye drops | DRUG | Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Placebo (Vehicle for Cyclosporine) | DRUG | Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
Inclusion Criteria: * Patient is scheduled for bilateral LASIK surgery * Patient is in good general health * Eye glasses prescription of -1 to -8 Exclusion Criteria: * Significant Dry Eye * Presence of eye disease * Uncontrolled systemic disease * Previous use of RESTASIS®
Cyclosporine 0.010% eye is an investigational ophthalmic formulation being studied in patients who have undergone Laser In Situ Keratomileusis, commonly known as LASIK. It is being evaluated in a Phase 2 clinical trial for this post-LASIK patient population. It is not described as approved for any indication.
Cyclosporine 0.010% eye targets PPIA, also known as cyclophilin A. PPIA is a peptidyl-prolyl isomerase, and the drug acts as a modulator of this target. This molecular target is the basis for the drug's activity in the ophthalmic setting being studied.
Cyclosporine 0.010% eye is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor associated with the clinical development of this ophthalmic formulation.
Cyclosporine 0.010% eye is in Phase 2 development. The single registered trial for this formulation is a completed Phase 2 study, and no active trials are currently listed. The drug remains investigational and is not described as FDA approved.
Cyclosporine 0.010% eye has been studied in one clinical trial, NCT00991458, titled Study of Cyclosporine in Post-LASIK Patients. That Phase 2 trial was completed, enrolled 621 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.
Yes, Cyclosporine 0.010% eye and Cyclosporine 0.010% eye drops refer to the same ophthalmic product. The eye drop form is the alternative name used for this formulation, which is being developed by AbbVie Inc. under the ticker ABBV.