The Sami Labs/Sabinsa research group developed a stable formulation of forskolin eye drops for use in the management of ocular hypertension and glaucoma. An Investigational New Drug (IND) application for this product is in process in India . Based on promising Phase I and Phase II clinical trials, a Phase III clinical trial was planned as part of the IND protocol. Sami Labs Ltd, Sabinsa's research and manufacturing group in India , recently received clearance from the Drugs Controller General of India (DCGI) to conduct these trials. These trials will be conducted by Clinworld. The multicenter trial will be carried out at six centers in Bombay , Delhi and Bangalore ), and the eye drops will be tested on one hundred patients.
Glaucoma is a condition in which the pressure in the eye is too high, due to an imbalance between the formation of aqueous humor in the eye and its absorption in or drainage out of the eye. Eventually, as the pressure builds up, the blood vessels nourishing the optic nerve are constricted, resulting in irreversible damage to the nerve and impaired vision culminating in blindness, if left untreated. Available oral and topical therapies are associated with side effects. Such side effects are not encountered with the natural formulation, as evidenced in the Phase I and Phase II trials. Forskolin is insoluble in water and therefore difficult to formulate into clear compositions for ocular application. The patent pending forskolin eye drops composition contains natural forskolin from Coleus forskohlii solubilized in water by using an innovative method.
USDA Plans New Study with SeleniumSeLECT ®
The United States Department of Agriculture is planning to conduct a clinical study to determine the minimum serum levels of selenium needed to support health and well being. SeleniumSeLECT was selected as the bioavailable source of supplemental selenium for this study.