Ben Simon GJ, Bakalash S, Aloni E, Rosner M A rat model for acute rise in intraocular pressure: immune modulation as a therapeutic strategy. Am J Ophthalmol. 2006 Jun;141(6):1105-11.
Budenz DL, Chang RT, Huang X, Knighton RW, Tielsch JM Reproducibility of retinal nerve fiber thickness measurements using the stratus OCT in normal and glaucomatous eyes. Invest Ophthalmol Vis Sci. 2005 Jul;46(7):2440-3.
Hains BC, Waxman SG Neuroprotection by sodium channel blockade with phenytoin in an experimental model of glaucoma. Invest Ophthalmol Vis Sci. 2005 Nov;46(11):4164-9.
Lo AC, Black JA, Waxman SG Neuroprotection of axons with phenytoin in experimental allergic encephalomyelitis. Neuroreport. 2002 Oct 28;13(15):1909-12.
Willmore LJ Antiepileptic drugs and neuroprotection: current status and future roles. Epilepsy Behav. 2005 Dec;7 Suppl 3:S25-8. Epub 2005 Oct 18. Review.
Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
