Trial | NCT01430923  Report issue

Title

Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    latanoprost ...

  • Study Participants

    30
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.
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 Started
Sep 30
2011
Primary Completion
May 31
2012
Study Completion
Aug 31
2012
Anticipated
Last Update
Jul 12
2012
Estimate

Drug refrigeration free latanoprost

latanoprost Eye drops 0.005% once daily, 3 months

  • Other names: Auroprost RT

Drug latanoprost eye drops

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

  • Other names: Auroprost

Refrigeration free Latanoprost Experimental

Latanoprost refrigeration free formulation as per randomization schedule.

latanoprost 2-8˚ C Active Comparator

latanoprost stored at 2-8˚ C

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
No Results Posted