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. 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.
MedicalResearch.com: What are the main findings?
Response: At all post-randomization visits, the compounded therapy was non-inferior to standard therapy. In fact, the compounded therapy actually resulted in IOPs that were between 1 and 3 mm Hg lower than standard therapy. Additionally, we saw that although corneal staining (a sign of preservative toxicity) remained stable in the standard multi-drop therapy group, the group using the compounded therapy improved in terms of corneal staining.
MedicalResearch.com: Is there anything else you would like to add?
Response: A compounded medication containing 4 topical intraocular pressure-lowering molecules (timolol, brimonidine, dorzolamide and latanoprost) was not inferior compared to the standard regimen and may show a greater absolute intraocular pressure reduction than the control. We found no evidence of additional safety problems associated with the use of compounded medications vs. the standard regimen, although the compounded therapies are not FDA approved.
Compared with the standard regiment, the compounded drops were associated with lower levels of corneal surface lesions – this can potentially be explained by the lower levels of preservatives in the compounded agents compared to the standard regimen. Inherently there are many benefits to combining four medications into a single bottle. These benefits include a lower amount of preservative exposure to patient, the use of fewer bottles, an easier dosing schedule, and potential cost savings.
A Compounded, Fixed Combination of Latanoprost 0.005%, Dorzolamide Hydrochloride 2%, Timolol Maleate 0.5%, Brimonidine Tartrate 0.2%, Compared to Standard Therapy for Glaucoma
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