Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
This trial is active, not recruiting.
|Conditions||glaucoma, open-angle, ocular hypertension|
|Treatments||refrigeration free latanoprost, latanoprost eye drops|
|Start date||September 2011|
|End date||May 2012|
|Trial size||30 participants|
|Trial identifier||NCT01430923, LATANOPROST/CIP/002/2011|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 3 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Patient between 18 and 80 years of age - Newly diagnosed Primary Open-Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation, or Ocular hypertension. - Patient has a mean (or median) IOP of 24 and 36 mmHg in at least one eye - Patient has a best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye. - Patient should have the access / ability to refrigerate study drug. - Residence with 60 kms of Madurai Exclusion Criteria: - Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit. - Patient has a history of or current abnormal corneal sensation or any abnormality in either eye preventing reliable Goldmann applanation tonometry - Pupil in either eye that will not dilate sufficiently for adequate evaluation of the retina - Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any retinal disease in either eye that may be progressive during the study - Patient who has significant ocular symptoms or signs such as photophobia, flashes or streaks of light, metamorphopsia, diplopia, or transient loss of vision in either eye. - Patient has had intraocular surgery (e.g., cataract extraction) in either eye within 4months prior to Screening visit. - Patient is aphakic or has, in the judgement of the investigator, risk for ocular inflammation
|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|
|Principal investigator||Dr. Manju R Pillai, MBBS.,|
|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.|
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