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Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension - NCT00947661-(Clinical Trial 716988)



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City:  San Antonio
State:  
TX
Zip Code:
Conditions: Open Angle Glaucoma - Ocular Hypertension
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Men and women aged ≥ 18 years. - Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG). - Unmedicated IOP ≥ 22 mmHg in one or both eyes. - Given informed consent. - Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test. Exclusion Criteria: - Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator). - Intraocular conventional surgery or laser surgery within the past six months. - Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months. - Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy. - Ocular trauma within the past 3 months. - Progressive retinal or optic nerve disease apart from glaucoma. - Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye. - Any abnormality preventing stable applanation tonometry. - Use of contact lens for the duration of the study. - Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber. - Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe. - Clinically significant systemic disease which might interfere with the study. - History of non-compliance to medical regimens or unwilling to comply with the study protocol. - Participation in another clinical study within the last thirty (30) days.
Study is available at: David Shulman
San Antonio, TX
United States

Primary Contact:
Medical Advisor, M.D.
Phone: +91-22-66455645
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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