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Lessons Learned

How do you see the OPI index being integrated into an FDA submission?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

Have topical agents or systemic drugs been used to treat dry eye?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

What do we know about the enervation of the meibomian gland? What regulates MG lipid secretion?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

Is MGD part of the differential diagnosis of dry eye or at the core of dry eye?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

What is the effect of dry eye chamber patient selection on labeling language for drug indications?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

How do Dry Eye chamber results correlate from mice to humans?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

What is the value of quality of life questionnaires in dry eye studies?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

Is mean change from baseline in a sign or symptom an acceptable endpoint for primary approval?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

What endpoints might be appropriate for studying a neurotrophy dry eye product candidate?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process

Is OPI a validated endpoint? How it might be used towards an FDA approval?

The Inaugural Dry Eye Summit 2010 Section: Lessons Learned in the Dry Eye Application Process