Journal of Clinical Trials
Open Access

Abstract

A Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Forskolin Eye Drops 1% in the Treatment of Open Angle Glaucoma – A Comparative Study

Muhammed Majeed, Kalyanam Nagabhushanam, Sankaran Natarajan, Priti Vaidyanathan and Suresh Kumar Karri

Objective: We assessed lowering of Intraocular Pressure (IOP) using a herbal formulation, Forskolin eye drops 1% w/v aqueous solution, in the treatment of open angle glaucoma. Methods: A double blind, randomized, controlled, multi centred trial was chosen as study design to assess the decrease in intraocular pressure with Forskolin 1% w/v aqueous solution eye drops. Ninety patients of either sex, above 18 years of age, suffering from open angle glaucoma with an intra ocular pressure of more than 24 mm/Hg were enrolled in the study. Tonometric readings with no instillation were recorded on baseline visit; the patients were given medication enough to last for the entire study duration and were advised to instill 2 drops thrice a day. The patients were then called for visit 2, i.e. end of 1st week, visit 3-2nd week, visit 4-3rd week, and visit 5-4th week. Conclusions: The trend towards a decrease in intraocular pressure was higher in the forskolin group for both the eyes as compared to the Timolol group and a reached statistical significance (p<0.05). Forskolin 1% w/v aqueous solution was found to be effective and safe in the treatment of open angle glaucoma. Results indicated Forskolin 1% w/v aqueous solution to be more effective than 0.5% Timolol eye drops and thus can be a good alternative treatment of choice in patients with open angle glaucoma.