Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
| Status: | Archived |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | September 2011 |
Comparison of the Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertension
A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy
and safety of 2 formulations of Latanoprost Ophthalmic Solution. Formulation 1 is the
currently marketed Latanoprost. Formulation 2 is an experimental Latanoprost with similar
active ingredient but containing a different preservative as that in Formulation 1. Patients
with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to
receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.
The study eye is defined as the eye with higher intraocular pressure (IOP) at enrollment or
if equal, patients with an even randomization number will be assigned left eye and an odd
number the right eye.
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