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Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Aurolab.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01430923
First received: September 7, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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 Intervention
Glaucoma, Open-Angle
Ocular Hypertension
Drug: refrigeration free latanoprost
Drug: latanoprost eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to evalate the change in intraocular pressure from baseline to end of treatment


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430923

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

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01430923     History of Changes
Other Study ID Numbers: LATANOPROST/CIP/002/2011
Study First Received: September 7, 2011
Last Updated: July 11, 2012
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Refrigeration free latanoprost

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Glaucoma
Vascular Diseases
Latanoprost
Ophthalmic Solutions
Antihypertensive Agents
Cardiovascular Agents
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014