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The purpose of this study is to:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refrigeration free Latanoprost | Experimental | Latanoprost refrigeration free formulation as per randomization schedule. |
|
| latanoprost 2-8˚ C | Active Comparator | latanoprost stored at 2-8˚ C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| refrigeration free latanoprost | Drug | latanoprost Eye drops 0.005% once daily, 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | to evalate the change in intraocular pressure from baseline to end of treatment | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Manju R Pillai, MBBS., | Araving Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye hospital | Madurai | Tamil Nadu | 625020 | India |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| latanoprost eye drops | Drug | latanoprost eye drops 0.005% w/v, once daily, 3 months |
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