The purpose of this study is to: * To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular hypertension. * To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients with open-angle glaucoma (OAG) or ocular hypertension.
Latanoprost refrigeration free formulation is developed to overcome difficulties on storing drugs at 2-8˚ C in consumer end and also to avoid risk during transition. This formulation has the best solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
latanoprost Eye drops 0.005% once daily, 3 months
latanoprost eye drops 0.005% w/v, once daily, 3 months
Aravind Eye hospital
Madurai, Tamil Nadu, India
Intraocular pressure
to evalate the change in intraocular pressure from baseline to end of treatment
Time frame: 3 months
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