Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430923
Recruitment Status : Unknown
Verified July 2012 by Aurolab.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2011
Last Update Posted : July 12, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Drug: refrigeration free latanoprost Drug: latanoprost eye drops

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Primary Completion Date : May 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Refrigeration free Latanoprost
Latanoprost refrigeration free formulation as per randomization schedule.
Drug: refrigeration free latanoprost
latanoprost Eye drops 0.005% once daily, 3 months
Other Name: Auroprost RT
Active Comparator: latanoprost 2-8˚ C
latanoprost stored at 2-8˚ C
Drug: latanoprost eye drops
latanoprost eye drops 0.005% w/v, once daily, 3 months
Other Name: Auroprost

Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 3 months ]
    to evalate the change in intraocular pressure from baseline to end of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01430923

Aravind Eye hospital
Madurai, Tamilnadu, India, 625020
Sponsors and Collaborators
Principal Investigator: Dr. Manju R Pillai, MBBS., Araving Eye Hospital

Responsible Party: Aurolab Identifier: NCT01430923     History of Changes
Other Study ID Numbers: LATANOPROST/CIP/002/2011
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Aurolab:
Refrigeration free latanoprost

Additional relevant MeSH terms:
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents