Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: refrigeration free latanoprost
* Drug: latanoprost eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refrigeration free Latanoprost<br>Latanoprost refrigeration free formulation as per randomization schedule. | Drug: refrigeration free latanoprost<br>* latanoprost Eye drops 0.005% once daily, 3 months<br>* Other names: Auroprost RT;|
| Active Comparator: latanoprost 2-8˚ C<br>latanoprost stored at 2-8˚ C | Drug: latanoprost eye drops<br>* latanoprost eye drops 0.005% w/v, once daily, 3 months<br>* Other names: Auroprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | to evalate the change in intraocular pressure from baseline to end of treatment | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refrigeration free latanoprost