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Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

refrigeration free latanoprost

latanoprost eye drops

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Refrigeration free latanoprost

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aravind Eye hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Refrigeration free Latanoprost

latanoprost 2-8˚ C

Arm Description

Latanoprost refrigeration free formulation as per randomization schedule.

latanoprost stored at 2-8˚ C

Outcomes

Primary Outcome Measures

Intraocular pressure

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01430923

First Posted

September 7, 2011

Last Updated

July 11, 2012

Sponsor

Aurolab

1. Study Identification

Unique Protocol Identification Number

NCT01430923

Brief Title

Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurolab

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

Keywords

Refrigeration free latanoprost

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Refrigeration free Latanoprost

Arm Type

Experimental

Arm Description

Latanoprost refrigeration free formulation as per randomization schedule.

Arm Title

latanoprost 2-8˚ C

Arm Type

Active Comparator

Arm Description

latanoprost stored at 2-8˚ C

Intervention Type

Drug

Intervention Name(s)

refrigeration free latanoprost

Other Intervention Name(s)

Auroprost RT

Intervention Description

latanoprost Eye drops 0.005% once daily, 3 months

Intervention Type

Drug

Intervention Name(s)

latanoprost eye drops

Other Intervention Name(s)

Auroprost

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular pressure

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Manju R Pillai, MBBS.,

Organizational Affiliation

Araving Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aravind Eye hospital

City

Madurai

State/Province

Tamilnadu

ZIP/Postal Code

625020

Country

India

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

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