Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
NCT01430923 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2012-07-12
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.
Conditions
- Glaucoma, Open-Angle
- Ocular Hypertension
Interventions
- DRUG
-
refrigeration free latanoprost
latanoprost Eye drops 0.005% once daily, 3 months
- DRUG
-
latanoprost eye drops
latanoprost eye drops 0.005% w/v, once daily, 3 months
Sponsors & Collaborators
-
Aurolab
lead OTHER
Principal Investigators
-
Dr. Manju R Pillai, MBBS., · Araving Eye Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2012-05-31
- Completion
- 2012-08-31
Countries
- India
Study Locations
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