Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Artificial Tears REFRESH ENDURA · 1 trial · 1 indication
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.
| Arm | Type | Description |
|---|---|---|
| RESTASIS® | ACTIVE_COMPARATOR | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
| REFRESH ENDURA® | ACTIVE_COMPARATOR | Artificial Tears (REFRESH ENDURA®) |
| Name | Type | Description |
|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) | DRUG | Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery |
| Artificial Tears REFRESH ENDURA® | DRUG | REFRESH ENDURA® administered twice daily in each eye for 6 months following 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
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Artificial Tears REFRESH ENDURA is used for Dry Eye Syndromes. It is an investigational small molecule being developed by AbbVie Inc. for the treatment of dry eye conditions. The drug is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities.
AbbVie Inc. (NYSE: ABBV) is the developer of Artificial Tears REFRESH ENDURA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for Dry Eye Syndromes. As of the latest data, the drug is in Phase 2 development.
Artificial Tears REFRESH ENDURA is in Phase 2 clinical development. It is an investigational drug for Dry Eye Syndromes and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug remains under investigation for its safety and efficacy.
Artificial Tears REFRESH ENDURA has one completed clinical trial, NCT00611403, titled "Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients." This Phase 2 study enrolled 137 participants with Dry Eye Syndromes in the United States. The trial was randomized, double-blind, and active-controlled.
Yes, Artificial Tears REFRESH ENDURA is associated with cyclosporine ophthalmic emulsion, as indicated by the clinical trial NCT00611403, which evaluated this treatment. The trial specifically studied the safety and efficacy of cyclosporine ophthalmic emulsion in post-LASIK patients with Dry Eye Syndromes.