Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

Ocular Hypertension Clinical Trial

Official title:

Randomized,Active Comparator-Controlled,Three Months,Open Label Clinical Trial to Compare Efficacy and Safety of Refrigeration-Free Latanoprost (0.005%) and Latanoprost (0.005%) Stored at Refrigeration Temperature in Patients With OAG or OHT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01430923
• Other study ID #: LATANOPROST/CIP/002/2011
• Status: Active, not recruiting
• Phase: N/A
• First received: September 7, 2011
• Last updated: July 11, 2012
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2012
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension

Intervention

Drug:
• refrigeration free latanoprost
latanoprost Eye drops 0.005% once daily, 3 months
• latanoprost eye drops
latanoprost eye drops 0.005% w/v, once daily, 3 months

Locations

Country	Name	City	State
India	Aravind Eye hospital	Madurai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	to evalate the change in intraocular pressure from baseline to end of treatment	3 months	No