Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01430923|
Recruitment Status : Unknown
Verified July 2012 by Aurolab.
Recruitment status was: Active, not recruiting
First Posted : September 9, 2011
Last Update Posted : July 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-Angle Ocular Hypertension||Drug: refrigeration free latanoprost Drug: latanoprost eye drops||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||August 2012|
Experimental: Refrigeration free Latanoprost
Latanoprost refrigeration free formulation as per randomization schedule.
Drug: refrigeration free latanoprost
latanoprost Eye drops 0.005% once daily, 3 months
Other Name: Auroprost RT
Active Comparator: latanoprost 2-8˚ C
latanoprost stored at 2-8˚ C
Drug: latanoprost eye drops
latanoprost eye drops 0.005% w/v, once daily, 3 months
Other Name: Auroprost
- Intraocular pressure [ Time Frame: 3 months ]to evalate the change in intraocular pressure from baseline to end of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430923
|Aravind Eye hospital|
|Madurai, Tamilnadu, India, 625020|
|Principal Investigator:||Dr. Manju R Pillai, MBBS.,||Araving Eye Hospital|