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Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

NCT ID: NCT01430923

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Keywords

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Refrigeration free latanoprost

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Refrigeration free Latanoprost

Latanoprost refrigeration free formulation as per randomization schedule.

Group Type EXPERIMENTAL

refrigeration free latanoprost

Intervention Type DRUG

latanoprost Eye drops 0.005% once daily, 3 months

latanoprost 2-8˚ C

latanoprost stored at 2-8˚ C

Group Type ACTIVE_COMPARATOR

latanoprost eye drops

Intervention Type DRUG

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

Interventions

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refrigeration free latanoprost

latanoprost Eye drops 0.005% once daily, 3 months

Intervention Type DRUG

latanoprost eye drops

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

Intervention Type DRUG

Other Intervention Names

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Auroprost RT Auroprost

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Manju R Pillai, MBBS.,

Role: PRINCIPAL_INVESTIGATOR

Araving Eye Hospital

Locations

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Aravind Eye hospital

Madurai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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LATANOPROST/CIP/002/2011

Identifier Type: -

Identifier Source: org_study_id