Status:
UNKNOWN
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
Lead Sponsor:
Aurolab
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 press...
Detailed Description
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 solu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01430923
Start Date
September 1 2011
End Date
August 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
Aravind Eye hospital
Madurai, Tamil Nadu, India, 625020