Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurolab
• Treatments: Latanoprost; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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