Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

NCT01430923 | Unknown

• 1 other identifier: LATANOPROST/CIP/002/2011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Keywords

Refrigeration free latanoprost

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  to evalate the change in intraocular pressure from baseline to end of treatment

  3 months

Study Arms (2)

Refrigeration free Latanoprost

EXPERIMENTAL

Latanoprost refrigeration free formulation as per randomization schedule.

Drug: refrigeration free latanoprost

latanoprost 2-8˚ C

ACTIVE COMPARATOR

latanoprost stored at 2-8˚ C

Drug: latanoprost eye drops

Interventions

refrigeration free latanoprost DRUG

latanoprost Eye drops 0.005% once daily, 3 months

Also known as: Auroprost RT

Refrigeration free Latanoprost

latanoprost eye drops DRUG

latanoprost eye drops 0.005% w/v, once daily, 3 months

Also known as: Auroprost

latanoprost 2-8˚ C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurolab: lead

Study Sites (1)

Aravind Eye hospital

Madurai, Tamil Nadu, 625020, India

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Dr. Manju R Pillai, MBBS.,

  Araving Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

IN (1)