MedicalResearch.com Interview with:
Nathan Radcliffe, MD
Senior Faculty, Ophthalmology Glaucoma and Cataract surgeon
Mount Sinai Health System
MedicalResearch.com: What is the background for this study?
Response: Glaucoma is a leading cause of blindness and the mainstay of therapy is to lower the intraocular pressure (IOP) with topical eye drops.
Up to 40% of patients may require more than one eye drop to control the disease, and yet taking more than one eye drop bottle can result in higher costs, more eye irritation, worse therapeutic compliance, and possibly worse outcomes, be sure to consult your eye surgeon before increasing any eye treatment to ensure it won’t do any further damage to the eye. Compounded therapies (not FDA approved, but made at the physician’s request by a compounding pharmacy) can be created to contain multiple glaucoma therapies in one bottle.
We sought to determine if a compounded solution containing three or four drops in one bottle could control glaucoma as well as three or four separate bottles (standard of care) in patients requiring three or four eye drop bottles to control glaucoma.
We performed a multi-center, randomized, observer-masked, parallel-group study comparing a compounded therapy containing latanoprost 0.05%, dorzolamide hydrochloride 2%, timolol maleate 0.5%, brimonidine tartrate 0.2% with 0.01% BAK to standard three or four bottle regaimins. We measured IOP and corneal staining (a sign of preservative toxicity), as well as other safety measures at week one, month one, two and three.