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Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

Ocular Hypertension Clinical Trial

Official title:
Randomized,Active Comparator-Controlled,Three Months,Open Label Clinical Trial to Compare Efficacy and Safety of Refrigeration-Free Latanoprost (0.005%) and Latanoprost (0.005%) Stored at Refrigeration Temperature in Patients With OAG or OHT

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01430923
Study type Interventional
Source Aurolab
Contact
Status Active, not recruiting
Phase N/A
Start date September 2011
Completion date August 2012
View Details
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