Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

Not Applicable

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: latanoprost eye drops; Drug: refrigeration free latanoprost

• Registration Number: NCT01430923
• Lead Sponsor: Aurolab

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 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.

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 solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
latanoprost 2-8˚ C	latanoprost eye drops	latanoprost stored at 2-8˚ C
Refrigeration free Latanoprost	refrigeration free latanoprost	Latanoprost refrigeration free formulation as per randomization schedule.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	3 months	to evalate the change in intraocular pressure from baseline to end of treatment

Trial Locations

Locations (1)

Aravind Eye hospital; 🇮🇳 Madurai, Tamilnadu, India