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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01430923
Other study ID # LATANOPROST/CIP/002/2011
Secondary ID
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


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
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